Document:

EX-10.2

 

     Pursuant to 17 CFR 240.24b-2, confidential information (indicated by [*])
has been omitted and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed with the
Commission.

Exhibit 10.2

PRODUCT DEVELOPMENT AND LICENSE AGREEMENT

BY AND BETWEEN

SHIRE LLC

AND

DURAMED PHARMACEUTICALS, INC.

DATED AS OF AUGUST 14, 2006

 

 

PRODUCT DEVELOPMENT AND LICENSE AGREEMENT

     This PRODUCT DEVELOPMENT AND LICENSE AGREEMENT (the “Agreement”) is dated as of August 14,
2006 by and among SHIRE LLC, a Kentucky limited liability company having a principal place of
business at 9200 Brookfield Court, Florence, Kentucky 41042 (together with its Affiliates,
“Shire”), SHIRE plc, a British public limited company having a principal place of business at
Hampshire International Business Park, Chineham, Basingstoke, England RG24 8EP, solely for purposes
of the provisions of Section 15.10 of this Agreement, and DURAMED PHARMACEUTICALS, INC., a Delaware
corporation having a place of business at 400 Chestnut Ridge Road, Woodcliff Lake, NJ 07677
(“Duramed”). Shire and Duramed are sometimes referred to herein individually as a “Party” and
together as the “Parties”.

RECITALS

     WHEREAS, Duramed is a pharmaceutical company focused on developing novel pharmaceuticals that
are safer and improved versions of widely-prescribed pharmaceutical products, including cervical
ring-based female healthcare products;

     WHEREAS, Shire is a worldwide, specialty pharmaceutical company engaged in the development,
manufacturing and marketing of pharmaceutical products;

     WHEREAS, Duramed has made a considerable investment in developing certain cervical and vaginal
ring technology;

     WHEREAS, Duramed has been conducting research and development on certain pharmaceutical
products that use such ring technology with certain pharmaceutical compounds; and

     WHEREAS, pursuant to the terms and conditions of this Agreement, the Parties desire to
cooperate on the continued research and development of such pharmaceutical products, and research
and development on other pharmaceutical products that use such ring technology with pharmaceutical
compounds, with the results of such cooperation to be commercialized by Shire in the Shire
Territory and by Duramed in the Duramed Territory.

     NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in this
Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties hereto hereby agree as follows:

ARTICLE 1

DEFINITIONS

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

     1.1 “Act” means the United States Federal Food, Drug and Cosmetics Act, as amended from time
to time, and the rules, regulations and guidelines promulgated thereunder.

 

 

     1.2 “Affiliate” means a Person that controls, is controlled by or is under common control with
a Party. For the purposes of this definition, the word “control” (including, with correlative
meaning, the terms “controlled by” or “under common control with”) means the actual power, either
directly or indirectly through one or more intermediaries, to direct the management and policies of
such Person, whether by the ownership of more than fifty percent (50%) of the voting stock of such
Person (it being understood that the direct or indirect ownership of a lesser percentage of such
stock shall not necessarily preclude the existence of control), or by contract or otherwise.

     1.3 “Business Day” means any day other than (a) Saturday or Sunday or (b) any other U.S.
Federal holiday.

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

     1.5 “cGLP” means current Good Laboratory Practices (i) as promulgated under the Act at 21
C.F.R. Part 58, as the same may be amended or re-enacted from time to time and (ii) as required by
Law in countries other than the United States where non-clinical laboratory studies are conducted.

     1.6 “cGMP” means all applicable standards relating to manufacturing practices for fine
chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished
pharmaceutical products, including (a) the principles detailed in the U.S. Current Good
Manufacturing Practices, 21 C.F.R. Parts 210 and 211 and The Rules Governing Medicinal Products in
the European Community, Volume IV Good Manufacturing Practice for Medicinal Products as each may be
amended from time to time, (b) the principles detailed in the ICH Q7A guidelines, (c) Laws
promulgated by any Governmental Authority in any country having jurisdiction over Manufacturing or
(d) guidance documents promulgated by any Governmental Authority in any country having jurisdiction
over Manufacturing (including but not limited to advisory opinions, compliance policy guides and
guidelines).

     1.7 “Clinical Trial Costs” means the [*] incurred by a Party or its Affiliates that is
specifically attributable or reasonably allocable to the conduct of clinical trials, and which is
payable (a) in the case of such clinical trials conducted by a clinical research organization
(“CRO”) or other Third Party on behalf of a Party or its Affiliates, as an out-of-pocket expense to
such a CRO, or (b) in the case of such clinical trials conducted by a Party or its Affiliates, at
such Party’s or its Affiliate’s actual cost including internal costs and direct expenses.

     1.8 “Collaboration Intellectual Property” means any Inventions, Improvements, Patents,
Know-How, or other intellectual property (whether patentable or not) (i) conceived, developed or
reduced to practice by either Party or its Affiliates, alone or jointly with each other or a Third
Party, during the Reimbursement Period in connection with any Development Plan or the Development
of Collaboration Products hereunder, or (ii) existing as of the date of this

2

 

Agreement and Controlled by Duramed and its Affiliates and related to Collaboration Products
or the Development, use or Commercialization of a Collaboration Product.

     1.9 “Collaboration Patents” means any and all Patents included in the Collaboration
Intellectual Property.

     1.10 “Collaboration Product” means:

	 	(a)	 	(i) a pharmaceutical product formulated as a cervical or
vaginal ring product that contains or comprises any Compound(s) initially
identified on Exhibit A hereto, (ii) any [*], and (iii) any and all
Improvements to the foregoing, in each case made during the Reimbursement
Period and for which Shire has reimbursed Development Expenses during the
Reimbursement Period; and
	 
	 	(b)	 	the levonorgestrel/ethinyl estradiol tablets 0-15 mg/0.03 mg
and ethinyl estradiol tablets 0.01 mg extended-cycle oral contraceptive product
of Duramed approved by the FDA on May 25, 2006 under New Drug Application
number [*] (“Seasonique”).

     1.11 “Commercialization” means any and all activities directed to the commercial
Manufacturing, marketing, offering for sale and selling of a pharmaceutical product. In addition,
“Commercialize” means to engage in any of the foregoing activities.

     1.12 “Compound” means any of the compounds set forth on Exhibit A.

     1.13 “Control” means with respect to any intellectual property right or other intangible
property, that a Party or one of its Affiliates owns or has a license or sublicense to such item or
right, and has the ability to grant access, license or sublicense in or to such right without
violating the terms of any agreement or other arrangement with any Third Party.

     1.14 “Development” means all activities relating to the research, development of, and
obtaining Regulatory Approval for, a pharmaceutical product, including all test method development,
stability testing, toxicology, formulation, process development, cGMP audits (excluding any audits
for commercial Manufacture), cGLP audits, cGCP audits, validation, quality assurance/quality
control development, preclinical and clinical testing and studies, regulatory affairs and outside
counsel regulatory legal services relating to any of the foregoing, and any activities relating to
the Manufacture of pharmaceutical products other than commercial quantities thereof.

     1.15 “Development Expenses” means the expenses incurred by Duramed or its Affiliates from and
after the Effective Date in carrying out a Development Plan and specifically attributable or
reasonably allocable to the Development of a Collaboration Product, including [*] incurred in
connection with (i) a Global Development Plan pursuant to Section 3.2.2(c), and/or (ii) seeking
Regulatory Approval of a Collaboration Product in [*]. Development Expenses shall include, but are
not limited to expenses arising from: [*] for the [*] a Governmental Authority to obtain Regulatory
Approval of a Collaboration Product in the United States; and [*] and[*] Collaboration Products[*].
Development Expenses shall exclude (i) [*], (ii) [*] incurred in

3

 

connection with seeking Regulatory Approval outside [*] other than in connection with a Global
Development Plan pursuant to 3.2.2(c), (iii) [*], and (iv) [*].

     1.16 “Diligent Efforts” means, with respect to a Party, the efforts and resources that would
be used by such Party consistent with prevailing pharmaceutical industry standards for a company of
similar size and scope to such Party with respect to a product or potential product at a similar
stage in its development or product life and of similar market potential taking into account
safety, efficacy and the competitiveness of alternative products in the market or under
development.

     1.17 “Drug Approval Application” means an application for Regulatory Approval required before
commercial sale or use of a pharmaceutical product as a drug in a regulatory jurisdiction,
including a new drug application (“NDA”) or supplemental new drug application or any amendments
thereto submitted to the FDA.

     1.18 “Duramed Territory” means the United States, Canada, Albania, Austria, Belarus, Bosnia
and Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Liechtenstein, Moldova, Poland,
Romania, Russia, Slovakia, Slovenia, Switzerland, Ukraine, Kazakhstan, Macedonia, Lithuania,
Latvia, Azerbaijan, Armenia and Georgia, and their respective territories and possessions;
provided, however, that in the event that Pliva, dd does not become an Affiliate of Duramed within
twelve (12) months of the Effective Date, the Duramed Territory shall thereafter mean only the
United States and Canada.

     1.19 “Effective Date” means the effective date as set forth in that certain Settlement
Agreement, dated as of August 14, 2006, by and between the Parties (the “Settlement Agreement”).

     1.20 “EMEA” means the European Medicines Agency or any successor agency thereto.

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

     1.22 “First Commercial Sale” means, with respect to a pharmaceutical product and on a
country-by-country basis, the first commercial sale after receipt of Regulatory Approval of such
product in such country. Sales for clinical studies, compassionate use, named patient programs,
sales under a treatment IND, test marketing, any nonregistrational studies, or any similar instance
where the product is supplied with or without charge shall not constitute a First Commercial Sale.

     1.23 “GAAP” means generally accepted accounting principles in the U.S., consistently applied.

     1.24 “Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body,
commission, official or other instrumentality of (a) any government of any country, (b) a federal,
state, province, county, city or other political subdivision thereof or (c) any supranational body,
including without limitation the FDA and the EMEA.

4

 

     1.25 “Improvement” means any enhancement or modification of (a) a Collaboration Product’s or
Ring Product’s dosage, dosage form or indication, (b) the cervical or vaginal ring, for Ring
Products and Collaboration Products based on a cervical or vaginal ring, (c) a [*] that is not a
cervical or vaginal ring product, or (d) the process or method for the Manufacture of a
Collaboration Product or Ring Product, in each case whether or not patentable, that is developed by
or for, invented or acquired by, or comes under the Control of, Duramed or Shire or their
respective Affiliates during the Term; provided, however, that (x) with respect to a Ring Product,
or a Collaboration Product based on a cervical or vaginal ring, an Improvement shall not include
any modification or improvement not used for a cervical or vaginal ring product, and for
modifications or improvements used for a cervical or vaginal ring products, only to the extent used
for such products, (y) with respect to a [*] that is not a cervical or vaginal ring product, an
Improvement shall not include any other delivery system or formulation involving the same compound;
provided, however, that if Duramed ceases development of such [*] or an NDA for such [*] was not
approved, and Duramed commences development of another delivery system or formulation involving the
same compound for such [*] during the Reimbursement Term, such delivery system or formulation
involving such compound shall be included as an Improvement, and (z) with respect to a
Collaboration Product, Improvements shall not include any active pharmaceutical ingredient other
than the applicable Compound, and with respect to a Ring Product, Improvements shall not include
any compounds other than [*].

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

     1.27 “Invention” means any discovery (whether patentable or not) conceived during the Term and
potentially useful for the Manufacture, use, Development or Commercialization of a product.

     1.28 “Know-How” means any non-public information, results and data of any type whatsoever, in
any tangible or intangible form whatsoever, including without limitation, databases, ideas,
discoveries, inventions, improvements, trade secrets, practices, methods, tests, assays,
techniques, specifications, processes, formulations, formulae, knowledge, know-how, skill,
experience, materials, including pharmaceutical, chemical and biological materials, products and
compositions, scientific, technical or test data (including pharmacological, biological, chemical,
biochemical, toxicological and clinical test data), clinical study protocols, analytical and
quality control data, stability data, studies and procedures, drawings, plans, designs, diagrams,
sketches, technology, documentation, and patent-related and other legal information or
descriptions.

     1.29 “Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders, judgments
and/or ordinances of any Governmental Authority.

     1.30 “Losses” means any and all liabilities, damages, fines, penalties, deficiencies, losses
and expenses (including interest, court costs, amounts paid in settlement, reasonable fees of
attorneys, accountants and other experts or other reasonable expenses of litigation or other
proceedings or of any claim, default or assessment); provided, however, that the term “Losses”

5

 

shall not include any special, consequential, indirect, punitive or similar damages, except to
the extent actually paid by a Party pursuant to any Third Party Claim.

     1.31 “Manufacture” means all activities related to the manufacturing of a pharmaceutical
product, or any ingredient thereof, for Development or for commercial sale, packaging, in-process
and finished product testing, release of product or any component or ingredient thereof, quality
assurance activities related to manufacturing and release of product, ongoing stability tests and
regulatory activities related to any of the foregoing.

     1.32 “Patent” means (a) patents, re-examinations, reissues, renewals, extensions,
supplementary protection certificates and term restorations, any confirmation patent or
registration patent or patent of addition based on any such patent, (b) pending applications for
patents, including without limitation continuations, continuations-in-part, divisional, provisional
and substitute applications, and inventors’ certificates, (c) all foreign counterparts of any of
the foregoing, and (d) all priority applications of any of the foregoing.

     1.33 “Patent Expenses” means the fees and expenses of outside counsel and payments to Third
Parties incurred after the Effective Date in connection with the preparation, filing, prosecution
and maintenance of the Collaboration Patents, including the costs of patent interference and
opposition proceedings, net of any reimbursement of such expenses by Third Parties.

     1.34 “Person” means any natural person, corporation, firm, business trust, joint venture,
association, organization, company, partnership or other business entity, or any government, or any
agency or political subdivisions thereof.

     1.35 “Regulatory Approval” means all approvals (including, without limitation, where
applicable, pricing and reimbursement approval and schedule classifications), product and/or
establishment licenses, registrations or authorizations of any regional, federal, state or local
regulatory agency, department, bureau or other governmental entity, necessary for the manufacture,
use, storage, import, export, transport, offer for sale, or sale of a pharmaceutical product in a
regulatory jurisdiction.

     1.36 “Ring Intellectual Property” means (i) Collaboration Intellectual Property and (ii) any
Patents and Know-How (whether patentable or not) existing as of the date of this Agreement and
Controlled by Duramed and its Affiliates and related to pharmaceutical products formulated as a
cervical or vaginal ring.

     1.37 “Ring Product” means a cervical or vaginal ring product containing the pharmaceutical
product known as [*], and any Improvements thereto created by Shire pursuant to the license granted
under Section 10.1.

     1.38 “Shire Territory” means all countries in the world, together with their territories and
possessions, other than the countries, territories and possessions that are part of the Duramed
Territory.

     1.39 “Shire Territory Global Development Expenses” means those Development Expenses of Duramed
approved under the Global Development Plan solely with respect to

6

 

obtaining Regulatory Approval of Collaboration Products in the Shire Territory. For the
avoidance of doubt, any other Development Expenses of Duramed approved under the Global Development
Plan, including for obtaining Regulatory Approval of Collaboration Products in the United States
shall not be considered Shire Territory Global Development Expenses.

     1.40 “Supply Agreement” means the supply agreement between Duramed and Shire for the supply of
finished Collaboration Products attached hereto as Exhibit B.

     1.41 “Third Party” means any entity other than Duramed or Shire or their respective
Affiliates.

     1.42 “Valid Claim” means (a) any claim of an issued and unexpired patent within a Patent which
has not been held unenforceable or invalid by a court or other governmental agency of competent
jurisdiction in an unappealed or unappealable decision, and which has not been disclaimed or
admitted to be invalid or unenforceable through reissue or otherwise, or (b) a pending claim in a
pending patent application within a Patent. Notwithstanding subsection (b) above, in the event
that a pending claim in a pending patent application does not issue as a valid and enforceable
claim in an issued patent within seven (7) years after the earliest date from which such patent
application claims priority, such a pending claim shall not be a Valid Claim, unless and until such
pending claim subsequently issues as a claim in an issued patent meeting the criteria set forth in
clause (a) above, in which case such claim shall be reinstated and be deemed to be a Valid Claim as
of the date of issuance of such patent.

     Interpretation. Unless the context of this Agreement otherwise requires, (a) words of one gender
include the other gender; (b) words using the singular or plural number also include the plural or
singular number, respectively; (c) the terms “hereof,” “herein,” “hereby,” and other similar words
refer to this entire Agreement; (d) “including” shall be deemed followed by “without limitation”,
“but not limited to” or words of similar meaning; and (e) the terms “Article” and “Section” refer
to the specified Article and Section of this Agreement. Whenever this Agreement refers to a number
of days, unless otherwise specified, such number shall refer to calendar days.

Additional Definitions. Each of the following definitions is set forth in the Section of this
Agreement indicated below:

	 	 	 
	Agreement

	 	Preamble
	Breaching Party

	 	Section 14.2
	Carryover Expenses

	 	Section 7.2.1
	Ceased Collaboration Product

	 	Section 14.3.1
	Collaboration Manager

	 	Section 2.4
	Collaboration Product INDs

	 	Section 13.3(b)
	Confidential Information

	 	Section 11.1.1
	Development Plan

	 	Section 3.2.1
	Disclosing Party

	 	Section 11.1.1
	Dollars

	 	Section 17.7
	Duramed

	 	Preamble
	Duramed Marks

	 	Section 12.7.3

7

 

	 	 	 
	Global Development Plan

	 	Section 3.2.2(c)
	Indemnification Claim Notice

	 	Section 15.2
	Indemnified Party

	 	Section 15.2
	Indemnifying Party

	 	Section 15.2
	Indemnitee

	 	Section 15.2
	Indemnitees

	 	Section 15.2
	Maximum Annual Reimbursement Amount

	 	Section 7.2.1
	Maximum Quarterly Reimbursement Amount

	 	Section 7.2.1
	Maximum Reimbursement Amount

	 	Section 7.2.1
	Milestone Payments

	 	Section 7.2.1
	NDA

	 	Section 1.17
	Notifying Party

	 	Section 14.2
	Parties

	 	Preamble
	Party

	 	Preamble
	Receiving Party

	 	Section 11.1.1
	Recovery

	 	Section 12.4.2(c)(iv)
	Reimbursement Period

	 	Section 7.2.1
	Reimbursable Expenses

	 	Section 7.2.1
	[*]

	 	Section 3.4
	[*]

	 	Section 3.4
	[*]

	 	Section 3.4
	[*]

	 	Section 3.4
	[*]

	 	Section 3.4
	Representatives

	 	Section 16.1
	Seasonique

	 	Section 1.10
	Settlement Agreement

	 	Section 1.19
	Shire

	 	Preamble
	Shire Marks

	 	Section 12.7.3
	Steering Committee

	 	Section 2.4
	Term

	 	Section 14.1
	Third Party Claim

	 	Section 15.1.1
	$

	 	Section 17.7

ARTICLE 2

PRODUCT DEVELOPMENT

     2.1 General. The general purpose of this Agreement is the Development and Commercialization
of Collaboration Products.

     2.2 Exclusive Development of Certain Ring Products. Duramed acknowledges and agrees that
during the Reimbursement Period, all Development of pharmaceutical products comprising a cervical
or vaginal ring that contains or comprises any of the Compound(s) identified on Exhibit A
hereto by Duramed or its Affiliates, shall be undertaken exclusively with Shire pursuant to the
terms of this Agreement.

8

 

     2.3 Collaboration Managers. Each Party shall appoint a senior representative having a general
understanding of development, regulatory, manufacturing and marketing issues to act as its
Collaboration Manager (a “Collaboration Manager”). Each Collaboration Manager shall be primarily
responsible for facilitating the flow of information and otherwise promoting communications and
collaboration between the Parties and also internally within the respective Parties. Each
Collaboration Manager shall also be responsible for:

          (a) facilitating coordination among the various functions representatives of Duramed or Shire,
as appropriate; and

          (b) providing single-point communication for seeking consensus both internally within the
respective Party’s organization and together regarding strategy, planning, development, regulatory
and manufacturing issues.

     2.4 Steering Committee. As soon as practicable after the Effective Date, the Parties shall
form a Steering Committee (the “Steering Committee”), which shall function in accordance with the
Steering Committee charter attached hereto as Exhibit C. The members of the Steering
Committee shall cooperate in good faith to effectively implement this Agreement and to amicably
resolve any disputes or disagreements related to the implementation hereof.

ARTICLE 3

DEVELOPMENT OF COLLABORATION PRODUCTS

     3.1 Overview. Subject to the terms and conditions of this Agreement, (a) Duramed shall be
responsible for the Development of Collaboration Products for Commercialization in the Duramed
Territory, and (b) Shire shall be responsible for the Development of Collaboration Products for
Commercialization in the Shire Territory.

     3.2 Development Plans.

          3.2.1 Scope. The Development of each Collaboration Product under this Agreement shall be
governed by a development plan (each, a “Development Plan”). Each Development Plan shall be
developed by the responsible Party for review and comment by the Steering Committee, with the
overall objective of achieving the commercial potential of the Collaboration Product. Each
Development Plan shall describe the proposed overall program of Development for the Collaboration
Product for each indication in the Duramed Territory and Shire Territory, as applicable, including
[*] and [*] and [*] Regulatory Approval, as well as [*] Drug Approval Applications and Regulatory
Approvals. Each of Duramed’s Development Plans shall include a budget for Development Expenses,
including separately [*] during the Reimbursement Period.

          3.2.2 Preparation and Review of Development Plans.

               (a) The Development Plan for the Development by Duramed of Collaboration Products for
Commercialization in the Duramed Territory shall be prepared by Duramed and shall be delivered to
the Steering Committee. Duramed shall consider in good faith any comments from the Steering
Committee. The current Development Plans for existing Collaboration Products are attached as
Exhibit D hereto.

9

 

               (b) The Development Plan for the Development by Shire of Collaboration Products for
Commercialization in the Shire Territory shall be prepared by Shire and shall be delivered to the
Steering Committee. Shire shall consider in good faith any comments from the Steering Committee.

               (c) In the event the Steering Committee unanimously agrees that a Collaboration Product (or
any aspect of its Development) should be Developed under a global Development program, the Steering
Committee shall prepare a global Development Plan (each, a “Global Development Plan”). Once a
Global Development Plan is agreed to, [*] under such Global Development Plan. The Development
Expenses incurred in the conduct of Development under a Global Development Plan shall be subject to
reimbursement pursuant to Section 7.2.

          3.2.3 Updates to Development Plans. As early as necessary in [*] beginning with the [*] after
the Effective Date, or otherwise as may be required during any [*], Duramed, Shire or the Steering
Committee, as applicable, shall update and prepare the Development Plan for any Collaboration
Products for the following [*] to take into account completion, commencement or cessation of
Development activities not contemplated by the then-current Development Plan, and submit such
proposed, updated Development Plan to the Steering Committee for its review and comment no later
than [*].

          3.2.4 Diligence. Each Party shall use Diligent Efforts to carry out the Development of each
Collaboration Product for Commercialization. Notwithstanding the foregoing, each Party
acknowledges that the other Party makes no representations and/or warranties that any Development
Plan will be successful or that the activities hereunder will result in any Collaboration Products
suitable for Commercialization.

     3.3 [*] of Collaboration Products. Duramed shall have the right, [*] Development of a
then-existing Collaboration Product. Duramed shall not directly or indirectly, alone or with or
through a Third Party, [*] Development [*] Collaboration Product[*] provided, however, that in the
event [*], Duramed shall have the right [*] Development of such [*]Collaboration Product [*]
hereunder to the [*] Development. If Duramed [*] Collaboration Product [*] Development [*] in the
[*] in respect of which [*], Shire may [*] Development and Commercialization of such Collaboration
Product [*]; provided, however, [*]Development.

     3.4 [*]. In the event that Duramed [*] Development of a [*] Collaboration Product, Duramed
may, [*] such Collaboration Product [*]. Duramed shall deliver to Shire a [*] Development of the
Collaboration Product [*]. Shire shall have [*] in which to [*] Duramed that it [*] for failing
[*] set forth in this Section 3.4. In delivering any [*], Shire shall specify what [*] to complete
its [*] of the [*]. Duramed shall use its reasonable best efforts to provide Shire any [*] within
[*]of receipt of the [*]. Shire may not [*] so long as (i) such [*] is in the [*]; (ii) such [*]
and [*] reasonably demonstrate that such [*] has [*] of at least [*] in [*], provided that any [*]
having the [*] to achieve at least [*] in [*] in the United States, as [*], shall be deemed to
satisfy this requirement; and (iii) Duramed has the [*] in the Shire Territory.

10

 

ARTICLE 4

REGULATORY ACTIVITIES

          4.1 General Obligations. Duramed shall be responsible for, and use Diligent Efforts in,
preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration
Products in the Duramed Territory. Shire shall be responsible for, and use Diligent Efforts in,
preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration
Products in the Shire Territory. In furtherance of the foregoing, Shire shall have sole discretion
with respect to preparing and filing Drug Approval Applications and seeking Regulatory Approvals
for Collaboration Products from the EMEA in all European Union member states, regardless of whether
any countries within the Duramed Territory are members of the European Union, provided that, [*]
seeking Regulatory Approvals for a Collaboration Product [*] of the First Commercial Sale of such
Collaboration Product (and the [*] includes any [*]), Duramed shall [*] Regulatory Approval for
such Collaboration Product [*].

          4.2 Transfer of Data to Shire. Within [*] after the Effective Date, Duramed shall provide to
Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled
as of the Effective Date with respect to the existing Collaboration Products, including any study
reports in draft or final form. Thereafter on [*], Duramed shall provide to Shire copies of all
such data (including any data compiled in support of a Drug Approval Application) as soon as
reasonably practicable after such data becomes available or compiled, including any drafts and
final versions of any study reports. All disclosures under this Section 4.2 shall be delivered in
electronic format. During the Reimbursement Period, on [*], Shire shall provide to Duramed [*]
Inventions and Improvements [*] Shire or its Affiliates, [*], during the previous [*].

          4.3 Transfer of Data to Duramed. On [*], Shire shall provide to Duramed copies of all
substantive or material Manufacturing, pre-clinical and clinical data compiled by or on behalf of
Shire with respect to the Collaboration Products (including any data compiled in support of a Drug
Approval Application) as soon as reasonably practicable after such data becomes available or
compiled, including any drafts and final versions of any study reports. All disclosures under this
Section 4.3 shall be delivered in electronic format. During the Reimbursement Period, on [*],
Shire shall provide to Duramed [*] Inventions and Improvements [*] Shire or its Affiliates [*],
during the previous [*].

          4.4 Right of Reference.

               4.4.1 Duramed shall permit Shire access to and grant Shire the right to reference and use, for
purposes of the Collaboration Products, all data, regulatory filings and regulatory communications
associated with any submissions for Regulatory Approval or other issues associated with any
Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of
a Collaboration Product in the Shire Territory, or in connection with any Regulatory Approval
process within the European Union, including without limitation with the EMEA. To the extent that
any such data, regulatory filings or regulatory communications are held by a Third Party, then
Duramed shall arrange direct access to the portions of such data, regulatory filings or regulatory
communications that are relevant to the activities of Shire that are contemplated by this
Agreement.

11

 

               4.4.2 Shire shall permit Duramed access to and grant Duramed the right to reference and use,
for purposes of the Collaboration Products, all data, regulatory filings and regulatory
communications associated with any submissions for Regulatory Approval or other issues associated
with any Collaboration Product, that is or would be relevant to Duramed’s Development or
Commercialization of a Collaboration Product in the Duramed Territory. To the extent that any such
data, regulatory filings or regulatory communications are held by a Third Party, then Shire shall
arrange direct access to the portions of such data, regulatory filings or regulatory communications
that are relevant to the activities of Duramed that are contemplated by this Agreement.

          4.5 Meetings.

               4.5.1 In the event that Shire desires Duramed to participate in any meeting, discussion or
substantive telephone conference call with any Governmental Authority relating to any Drug Approval
Application or Regulatory Approval for Collaboration Products in the Shire Territory or such
meetings, discussions or substantive telephone conferences pertaining to member states of the
European Union outside the Shire Territory, Shire shall provide Duramed with reasonable advance
notice of any such meeting, discussion or conference call and Duramed shall participate with Shire.
Shire shall reimburse Duramed for its reasonable out-of-pocket expenses incurred in connection
with such participation, and any such reimbursement shall not be credited against the reimbursement
provided for in Section 7.2.

               4.5.2 In the event that Duramed desires Shire to participate in any meeting, discussion or
substantive telephone conference call with any Governmental Authority relating to any Drug Approval
Application or Regulatory Approval for Collaboration Products in the Duramed Territory other than,
subject to Section 4.1, those member states in the European Union in the Duramed Territory for
which Shire is responsible, Duramed shall provide Shire with reasonable advance notice of any such
meeting, discussion or conference call and Shire shall participate with Duramed. Duramed shall
reimburse Shire for its reasonable out-of-pocket expenses incurred in connection with such
participation.

     4.6 Assistance. Subject to the terms of this ARTICLE 4, each Party agrees to provide the
other with all reasonable assistance and take all actions reasonably requested by the other Party
that are necessary or desirable to enable the other Party to comply with any Law applicable to the
Collaboration Products, including, but not limited to, meeting, reporting and other obligations to
maintain and update any Regulatory Approvals for the Collaboration Products.

     4.7 Compliance with Laws. Each Party and its Affiliates and permitted Third Party contractors
shall perform its responsibilities under this ARTICLE 4 in accordance with all applicable Laws,
including without limitation cGLPs, cGCPs and cGMPs.

ARTICLE 5

COMMERCIALIZATION OF COLLABORATION PRODUCTS

     5.1 Principles of Commercialization. Subject to the terms and conditions of this Agreement,
Duramed shall have the sole right and responsibility with respect to Commercializing Collaboration
Products in the Duramed Territory. Subject to the terms and

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conditions of this Agreement, Shire shall have the sole right and responsibility with respect
to Commercializing Collaboration Products in the Shire Territory.

     5.2 Shire Territory.

               5.2.1 For each Collaboration Product, Shire shall be solely responsible for handling all
returns, recalls, order processing, invoicing and collection, distribution, and inventory and
receivables arising from sales to Third Parties within the Shire Territory. Duramed may not accept
orders from a Third Party for a Collaboration Product or make sales for its own account (except to
Shire) or for Shire’s account in the Shire Territory. If Duramed receives any order for a
Collaboration Product in the Shire Territory, it shall refer such orders to Shire for acceptance or
rejection. Shire shall have the right and responsibility for establishing and modifying the terms
and conditions with respect to the sale of all Collaboration Products in the Shire Territory,
including any terms and conditions relating to or affecting the price at which the Collaboration
Products shall be sold, discounts available to managed care providers, any discount attributable to
payments on receivables, distribution of the Collaboration Products, and credits, price
adjustments, or other discounts and allowances to be granted or refused.

               5.2.2 In the event that Duramed desires to Commercialize a Collaboration Product in any
country of the Shire Territory, Duramed may so notify Shire in writing and the Parties shall meet
in person or by teleconference within [*] thereafter to discuss whether Shire desires to relinquish
its rights to Commercialize such Collaboration Product in such country and, if so, the Parties
shall discuss in good faith commercially reasonable terms to effectuate such transfer of rights.
Nothing in this Section 5.2.2 shall be deemed to limit any other rights of the Parties under this
Agreement.

     5.3 Duramed Territory.

               5.3.1 For each Collaboration Product, Duramed shall be solely responsible for handling all
returns, recalls, order processing, invoicing and collection, distribution, and inventory and
receivables arising from sales to Third Parties within the Duramed Territory. Shire may not accept
orders from a Third Party for a Collaboration Product or make sales for its own account (except to
Duramed) or for Duramed’s account in the Duramed Territory. If Shire receives any order for a
Collaboration Product in the Duramed Territory, it shall refer such orders to Duramed for
acceptance or rejection. Duramed shall have the right and responsibility for establishing and
modifying the terms and conditions with respect to the sale of all Collaboration Products in the
Duramed Territory, including any terms and conditions relating to or affecting the price at which
the Collaboration Products shall be sold, discounts available to managed care providers, any
discount attributable to payments on receivables, distribution of the Collaboration Products, and
credits, price adjustments, or other discounts and allowances to be granted or refused.

               5.3.2 In the event that Shire desires to Commercialize a Collaboration Product in any country
of the Duramed Territory, Shire may so notify Duramed in writing and the Parties shall meet in
person or by teleconference within [*] thereafter to discuss whether Duramed desires to relinquish
its rights to Commercialize such Collaboration Product in such country and, if so, the Parties
shall discuss in good faith commercially reasonable terms to

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effectuate such transfer of rights. Nothing in this Section 5.3.2 shall be deemed to limit
any other rights of the Parties under this Agreement.

          5.4 Shire Regulatory Responsibilities. With respect to the Shire Territory, Shire shall use
Diligent Efforts to obtain and maintain all regulatory filings and Regulatory Approvals in the
Shire Territory for each Collaboration Product Developed pursuant to this Agreement, including all
INDs and Drug Approval Applications. Except as provided in Section 4.1, as between the Parties,
Shire shall be solely responsible for all activities in connection with obtaining and maintaining
Regulatory Approvals required for the Commercialization of Collaboration Product in the Shire
Territory, including all Drug Approval Applications with the EMEA, regardless of whether any
countries within the Duramed Territory are member states of the European Union, including in all
cases communicating and preparing and filing all reports (including adverse drug experience
reports) with the applicable Governmental Authorities.

          5.5 Duramed Regulatory Responsibilities. With respect to the Duramed Territory, and except as
provided in Section 5.4, Duramed shall use Diligent Efforts to obtain and maintain all regulatory
filings and Regulatory Approvals in the Duramed Territory for each Collaboration Product Developed
pursuant to this Agreement, including all INDs and Drug Approval Applications. Except as otherwise
provided herein, as between the Parties, Duramed shall be solely responsible for all activities in
connection with obtaining and maintaining Regulatory Approvals required for the Commercialization
of Collaboration Product in the Duramed Territory, including communicating and preparing and filing
all reports (including adverse drug experience reports) with the applicable Governmental
Authorities.

          5.6 Pharmacovigilance. As soon as reasonably practicable following the Effective Date, the
pharmacovigilance departments of each of Duramed and Shire shall meet and determine the approach to
be taken for the collection, review, assessment, tracking and filing of information related to
adverse events associated with the Collaboration Products, consistent with the provisions of this
Section 5.6. Such approach shall be documented in a separate and appropriate written
pharmacovigilance agreement between Duramed and Shire. 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 such other Party to comply with its responsibility to report pharmacovigilance
information under this Section 5.6.

          5.7 Diligence in Commercialization. Duramed shall use Diligent Efforts to Commercialize the
Collaboration Products in the Duramed Territory; provided that Duramed shall have no specific
obligation to Commercialize the Collaboration Products in any particular country or countries.
Shire shall use Diligent Efforts to Commercialize the Collaboration Products in the Shire
Territory; provided that Shire shall have no specific obligation to Commercialize the Collaboration
Products in any particular country or countries..

     5.8 Commercialization Expenses. Duramed shall bear all costs in connection with the
Commercialization of Collaboration Products in the Duramed Territory. Shire shall bear all costs
in connection with the Commercialization of Collaboration Products in the Shire Territory.

     5.9 Compliance with Laws. Each Party or its permitted Third Party contractors shall perform
its responsibilities under this ARTICLE 4 in accordance with all applicable Laws.

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ARTICLE 6

MANUFACTURE AND EXPORTATION OF COLLABORATION PRODUCTS

     6.1 Manufacture and Supply.

          6.1.1 Manufacturing Process. Duramed shall use Diligent Efforts to develop a process for the
Manufacture of Collaboration Products and to scale up such process to a level sufficient to
Manufacture and supply clinical and commercial supplies of Collaboration Products for the Shire
Territory, including the preparation of filings necessary to obtain Regulatory Approval for the
Manufacture of Collaboration Products for sale in the Shire Territory and the selection of any
Third Party(ies) to engage in the Manufacture and supply of Collaboration Products and components
thereof. In the event that Duramed includes the filings referred to in this Section 6.1.1 in Drug
Master Files in the Duramed Territory, Shire may reference such Drug Master Files for countries in
the Shire Territory in which Shire seeks Regulatory Approval of Collaboration Products. Once such
filings are made, no changes to the process for the Manufacture of Collaboration Products for sale
in the Shire Territory shall be made without the written consent of Shire, such consent not to be
unreasonably withheld, unless such changes are required by Law.

          6.1.2 Supply of Collaboration Product. At the completion of each Development Plan, the
Parties shall establish a final finished dosage form for each Collaboration Product. Shire shall
purchase from Duramed, and Duramed shall supply to Shire, Collaboration Product in accordance with
the terms and conditions of the Supply Agreement.

     6.2 Specifications and Terms of Supply. Duramed shall establish the specifications, including
any necessary documentation, certificates of analysis and test results, for the Collaboration
Products to be Manufactured under this ARTICLE 6, in each case subject to the prior written
approval of Shire, such approval not be unreasonably withheld. The Parties shall endeavor to
maintain compatible specifications for Collaboration Products on a worldwide basis, and to minimize
the number of distinct specifications in different countries.

     6.3 Exportation of Collaboration Products by Duramed. Duramed shall not actively sell any
Collaboration Product outside the countries of the Duramed Territory, and shall not sell
Collaboration Product to any Person, inside the Duramed Territory knowing or having reason to
believe that the Collaboration Products are likely to be sold in the Shire Territory. Duramed
shall not market or promote the Collaboration Products in the Shire Territory.

     6.4 Exportation of Collaboration Products by Shire. Shire shall not actively sell any
Collaboration Product outside the countries of the Shire Territory, and shall not sell
Collaboration Product to any Person, inside the Shire Territory knowing or having reason to believe
that the Collaboration Products are likely to be sold in the Duramed Territory. Shire shall not
market or promote the Collaboration Products in the Duramed Territory.

ARTICLE 7

FINANCIAL TERMS

     7.1 Initial Reimbursement for Development Expenses. Shire shall pay to Duramed a one-time fee
equal to $25,000,000 within five (5) Business Days after the Effective Date. It is

15

 

intended that such payment serve as reimbursement to Duramed for Development Expenses that
Duramed has incurred up to the Effective Date. This fee shall be non-creditable and non-refundable
against any future obligations of Shire under this Agreement.

     7.2 Reimbursement of Development Expenses.

          7.2.1 Reimbursement. Subject to the terms and conditions contained herein, Shire shall pay to
Duramed, on a calendar quarterly basis, (i) reimbursements of amounts equal to Development Expenses
that are incurred by Duramed, and (ii) milestone payments for meeting the milestones set forth in
Schedule 7.2.1A and Schedule 7.2.1B (“Milestone Payments”). Shire shall pay such reimbursement to
Duramed for an eight (8) year period commencing on the Effective Date (the “Reimbursement Period”),
up to an aggregate amount of $140,000,000, provided, however, that such aggregate amount shall be
subject to reduction in connection with (a) Milestone Payments paid in respect of Seasonique, as
set forth on Schedule 7.2.1A, and (b) Milestone Payments paid in respect of the Ring Product, as
set forth on Schedule 7.2.1B (all such Milestone Payments, together with the Development Expenses
being referred to collectively as the “Reimbursable Expenses”). Milestone Payments shall be paid
at any time during the Term that the applicable milestone is met. Notwithstanding the foregoing,
and subject to Section 3.2.2(c), in no event shall the aggregate Reimbursable Expenses (including,
for the avoidance of doubt, all Milestone Payments and all Development Expenses) to be paid by
Shire hereunder exceed $140,000,000 (the “Maximum Reimbursement Amount”). In no event shall Shire
be required to pay Reimbursable Expenses in excess of [*] during any calendar year (the “Maximum
Annual Reimbursement Amount”). In addition, any Development Expenses in excess of [*] (the
“Maximum Quarterly Reimbursement Amount”) during any calendar quarter (irrespective of Milestone
Payments), that Duramed incurs shall never become a Reimbursable Expense, and shall not be counted
toward Reimbursable Expenses or the Maximum Reimbursement Amount. For purposes of determining the
Maximum Annual Reimbursement Amount or the Maximum Quarterly Reimbursement Amount, amounts for any
partial years or quarters will be prorated based on the number of days in such partial calendar
year or quarter. Subject to the foregoing, the amount of Reimbursable Expenses in any calendar
year in excess of [*], if any (“Carryover Expenses”), including any unreimbursed Carryover Expenses
from previous years, shall carry over to the first calendar quarter of the immediately following
calendar year during the Reimbursement Period and be reimbursed by Shire as part of the
Reimbursable Expenses for such calendar quarter until all Carryover Expenses have been recovered.
Carryover Expenses shall be subject to, and count toward, the Maximum Reimbursement Amount and the
Maximum Annual Reimbursement Amount, but shall not be subject to, or count toward, the Maximum
Quarterly Reimbursement Amount. In the event the Reimbursement Period expires prior to Duramed
having incurred Reimbursable Expenses equal to the Maximum Reimbursement Amount, Duramed shall have
no right to receive any further payment from Shire. During the Term of this Agreement, no
cessation or suspension by Shire of Development of Collaboration Product for the Shire Territory
shall affect Shire’s reimbursement obligations under this Section 7.2.1. Shire Territory Global
Development Expenses shall be reimbursable hereunder as Development Expenses but shall not be
subject to or count toward the Maximum Reimbursement Amount, the Maximum Annual Reimbursement
Amount or the Maximum Quarterly Reimbursement Amount.

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          7.2.2 Quarterly Forecasting. By February 28, May 31, August 31, and November 30 each year,
Duramed shall provide Shire with a forecast for the current calendar quarter, each calendar quarter
remaining in that calendar year and each quarter of the following calendar year, setting forth
Duramed’s reasonable projected Reimbursable Expense for each Collaboration Product together with
any forecast Carryover Expenses at the end of each of the current calendar year and the following
calendar year. Such forecasts shall be provided by Duramed to Shire in good faith.

          7.2.3 Quarterly Reporting. Within thirty (30) days after the end of each calendar quarter
during the Reimbursement Period, Duramed shall deliver to Shire a reasonably detailed report
setting forth the Reimbursable Expenses for each Collaboration Product that Duramed has incurred
during such calendar quarter. Shire shall pay such amount to Duramed within forty-five (45) days
after the end of each calendar quarter during the Reimbursement Period, or in any event within
fifteen (15) days after Shire’s receipt of the aforementioned report if it is not timely delivered
by Duramed after the end of the applicable calendar quarter.

          7.2.4 No Other Payments. Shire shall have no obligation to pay royalties or any other amounts
to Duramed in connection with the transactions contemplated under this Agreement other than as
expressly set forth in this ARTICLE 7 and as contemplated by the Supply Agreement. Duramed shall
be solely responsible for all Development Expenses (other than Shire Territory Global Expenses)
which are not Reimbursable Expenses, and all Development Expenses which are Reimbursable Expenses
in excess of the Maximum Reimbursement Amount.

          7.2.5 Shire Development Fees. Shire shall be solely responsible for all Development Expenses
it incurs with respect the Collaboration Products in the Shire Territory.

ARTICLE 8

PAYMENT TERMS

     8.1 Payment Method. All amounts due to either Party hereunder shall be paid in United States
Dollars by wire transfer in immediately available funds to an account designated by such Party.
Any payments or portions thereof due hereunder that are not paid by the date such payments are due
under this Agreement shall bear interest [*] at the lower of (a) the [*], on the due date (or, if
the due date is not a business day, on the last business day prior to such due date), or (b) the
[*] on the[*] such [*].

     8.2 Payment Schedules; Reports. The payments due pursuant to Sections 7.1 and 7.2 are due and
payable on the dates described therein. The Parties acknowledge that any expenses or costs
reported under this Agreement may be based upon estimates, which estimates shall be made in
compliance with GAAP consistently applied by such Party in accordance with past practice; provided
that when the actual results become known relative to any estimated amount, any difference between
the actual results and the estimate is reported and the next payment due hereunder related to such
estimated item is appropriately adjusted for such difference. The Parties acknowledge and agree
that any reports and payments relating to any cost, expense, or other financial amount shared
pursuant to this Agreement for the [*] of any [*]

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shall reflect [*] reconciliations and adjustments, if any, applicable to the previous [*]
reported results.

     8.3 Taxes. Duramed shall be responsible for any and all income or other taxes owed by Duramed
and required by applicable Law to be withheld or deducted from any of the payments made by or on
behalf of Shire to Duramed hereunder, and Shire may deduct from any amounts that Shire is required
to pay hereunder an amount equal to such taxes. The Parties shall reasonably cooperate in
connection with the other’s efforts to minimize liability for taxes, to the extent legally
permissible, and shall reasonably support each other in the event of an audit by any taxing
authority. Shire shall not be responsible for payment of any income, franchise, gross receipts or
personal property taxes paid by Duramed on Duramed’s income, capital, assets or gross sales as a
result of this Agreement.

     8.4 Records Retention; Audit.

          8.4.1 Record Retention. Each Party shall maintain complete and accurate books, records and
accounts used for the determination of expenses incurred in connection with the performance of
Development or Commercialization activities (including, in the case of Duramed, the calculation of
Development Expenses), in sufficient detail to confirm the accuracy of any payments required under
this Agreement, which books, records and accounts shall be retained by such Party for [*] after the
end of the period to which such books, records and accounts pertain, or longer as is required by
applicable Law.

          8.4.2 Audit. Shire shall have the right to have an independent certified public accounting
firm of internationally recognized standing, reasonably acceptable to Duramed, to have access
during normal business hours, and upon reasonable prior written notice, to such of the records of
Duramed as may be reasonably necessary to verify the accuracy of reimbursement amounts paid by
Shire under this Agreement for any calendar year ending not more than three (3) years prior to the
date of such request; provided, however, that, Shire shall not have the right to conduct more than
[*] in any [*] and that Shire shall not be permitted to audit the same period of time more than
[*]. The accounting firm shall disclose to Shire only whether the various expenses subject to
reimbursement under this Agreement are correct or incorrect and the specific details concerning any
discrepancies. [*] of such [*], in which case [*]. If Duramed disputes the findings pursuant to
this Section 8.4.2, the Parties shall meet and discuss such dispute. If such dispute is not
resolved within [*], then it shall be subject to ARTICLE 16.

          8.4.3 Payment of Additional Amounts. If, based on the results of any audit, (a) additional
payments are owed by Shire to Duramed under this Agreement, then Shire shall make such additional
payments, or (b) the payments previously made by Shire to Duramed under this Agreement are in
excess of the amounts that were actually required to be made, then Duramed shall return such excess
payments, in each case within [*] after the accounting firm’s written report is delivered to the
Parties. The provisions of Section 8.1 shall apply to such payment.

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ARTICLE 9

DURAMED LICENSE AND TECHNOLOGY TRANSFER

     9.1 Development License Grant. During the Term of the Agreement, Duramed hereby grants to
Shire a nonexclusive, worldwide, fully paid-up license under the Collaboration Intellectual
Property to Develop and use Collaboration Products for the purpose of Commercializing Collaboration
Products in the Shire Territory. Notwithstanding the foregoing nonexclusive license grant, Duramed
shall not undertake clinical trials of a Collaboration Product in any European Union country in the
Shire Territory without first obtaining the prior written consent of Shire.

     9.2 Commercialization License Grant. During the Term of the Agreement, Duramed hereby grants
to Shire an exclusive (even as to Duramed and its Affiliates), worldwide, fully paid-up license
under the Collaboration Intellectual Property to Commercialize Collaboration Products in the Shire
Territory. Following the Reimbursement Period, the license granted under the previous sentence
shall remain exclusive as to the Commercialization of then-existing Collaboration Products but
shall not restrict Duramed from using the Collaboration Intellectual Property for any other
purpose, including to Commercialize improved or alternative variants of such Collaboration
Products, or products that compete with such Collaboration Products.

     9.3 Technology Transfer in Event of Failure to Supply. In the event Duramed ceases
Development or Commercialization of any Collaboration Product and Shire desires to continue such
Development or Commercialization in the Shire Territory, then, pursuant to the Supply Agreement,
Duramed shall, at its option, either supply the applicable Collaboration Product to Shire or
facilitate the transfer of the manufacture of the applicable Collaboration Product to Shire or
Shire’s designee in accordance with Article VIII of the Supply Agreement.

ARTICLE 10

LICENSE RELATING TO RING PRODUCT

     10.1 License Relating to Ring Intellectual Property. Duramed hereby grants to Shire an
exclusive (even as to Duramed and its Affiliates), worldwide, fully paid-up, irrevocable and
perpetual license, with the right to grant sublicenses, under the Ring Intellectual Property,
solely to research, Develop, Manufacture, use, and Commercialize the Ring Product throughout the
world.

          10.2 Ring Technology Transfer. As soon as practicable following the Effective Date, the
Parties shall meet to discuss and identify the Know-How included in the Ring Intellectual Property
that Shire believes is most promising to successfully develop the Ring Product. Duramed shall in
good faith provide all reasonable information requested by Shire to assist Shire in identifying
such Know-How. Upon identifying such Know-How, Duramed shall, and shall cause its Affiliates to
disclose to Shire or an Affiliate designated by Shire, such Know-How to enable Shire to engage in
Development activities related to Ring Product in accordance with the licenses granted in Section
10.1. Notwithstanding the foregoing, Duramed makes no representations and/or warranties that the
Ring Product can be successfully Developed or

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Commercialized or that the Know-How disclosed hereunder will be sufficient for such
Development or Commercialization.

ARTICLE 11

CONFIDENTIALITY

     11.1 Confidential Information.

          11.1.1 Confidential Information. As used in this Agreement, the term “Confidential
Information” means all secret, confidential or proprietary information or data, whether
provided in written, oral, graphic, video, computer, electronic or other form, provided pursuant to
this Agreement or generated pursuant to this Agreement by one Party or its Affiliates (the
“Disclosing Party”) to the other Party or its Affiliates (the “Receiving Party”),
including but not limited to, information relating to the Disclosing Party’s existing or proposed
research, development efforts, patent applications, business or products, and any other materials
that have not been made available by the Disclosing Party to the general public. Confidential
Information of Duramed shall include all Collaboration Intellectual Property. Confidential
Information shall not include any information or materials that:

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

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

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

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

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

          11.1.2 Confidentiality Obligations. Each of Duramed and Shire shall keep confidential all
Confidential Information of the other Party with the same degree of care it maintains the
confidentiality of its own Confidential Information but in no event less than a reasonable degree
of care. Neither Party shall use such Confidential Information for any purpose other than in
performance of this Agreement or disclose the same to any other Person other than to such of its
and its Affiliates’ directors, managers, employees, independent contractors, agents or consultants
who are bound to confidentiality restrictions consistent with terms herein and who have a need to
know such Confidential Information to implement the terms of this Agreement or enforce its rights
under this Agreement. Upon termination of this Agreement, the Receiving

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Party shall return or destroy all documents, tapes or other media containing Confidential
Information of the Disclosing Party that remain in the possession of the Receiving Party and its
Affiliates or their directors, managers, employees, independent contractors, agents or consultants,
except that the Receiving Party may keep one copy of the Confidential Information in the legal
department files of the Receiving Party, solely for archival purposes. Such archival copy shall
continue to be subject to the provisions of this ARTICLE 11.

          11.1.3 Permitted Disclosure and Use. Notwithstanding Section 11.1.2, a Party may disclose
Confidential Information belonging to the other Party only to the extent such disclosure is
reasonably necessary to: (a) obtain Regulatory Approval to the extent such disclosure is made to a
Governmental Authority; (b) comply with or enforce any of the provisions of this Agreement; (c)
comply with Laws; or (d) comply with applicable stock exchange regulations. If a Party deems it
necessary to disclose Confidential Information of the other Party pursuant to this Section 11.1.3,
such Party shall give reasonable advance notice of such disclosure to the other Party to permit
such other Party sufficient opportunity to object to such disclosure or to take measures to ensure
confidential treatment of such information. In addition, notwithstanding Section 11.1.2, the
Parties shall cooperate to prepare standardized public responses to anticipated inquiries from the
public, press, stockholders, investors and/or analysts with respect to the activities hereunder.
Despite the foregoing, each Party agrees that the other Party is free to disclose this Agreement in
its entirety to the United States Federal Trade Commission and the United States Department of
Justice, or to any court with jurisdiction over the litigations settled under the Settlement
Agreement between Shire Laboratories Inc. and Barr Laboratories Inc. dated August 14, 2006.

          11.1.4 Unauthorized Disclosure. The Receiving Party acknowledges and agrees that the
Confidential Information of the Disclosing Party constitutes proprietary information and trade
secrets valuable to the Disclosing Party, and that the unauthorized use, loss or outside disclosure
of such Confidential Information shall be presumed to cause irreparable injury to the Disclosing
Party.

          11.1.5 Notification. The Receiving Party shall notify the Disclosing Party promptly upon
discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information,
and shall cooperate with the Disclosing Party in any reasonably requested fashion to assist the
Disclosing Party to regain possession of such Confidential Information and to prevent its further
unauthorized use or disclosure. The Receiving Party acknowledges that monetary damages may not be
a sufficient remedy for unauthorized disclosure of Confidential Information and that the Disclosing
Party may be entitled, without waiving other rights or remedies, to such injunctive or equitable
relief as may be deemed proper by a court of competent jurisdiction in the event of such
unauthorized disclosure.

     11.2 Confidentiality of this Agreement. The terms of this Agreement shall be Confidential
Information of each Party and, as such, shall be subject to the provisions of this ARTICLE 11.

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ARTICLE 12

OWNERSHIP OF INTELLECTUAL PROPERTY

     12.1 Ownership. Duramed shall be the exclusive owner of all right, title and interest in and
to all Collaboration Intellectual Property, and Shire hereby assigns to Duramed all right, title
and interest therein. Nothing herein shall be construed as granting Shire any rights in any of the
foregoing except as expressly provided herein. Shire shall, at the request of Duramed, perform any
acts that Duramed may reasonably deem necessary or desirable to evidence or confirm Duramed’s
ownership interest in the Collaboration Intellectual Property, including but not limited to making
further written assignments in a form determined by Duramed.

     12.2 Patent Filings. Duramed shall have the sole right to prepare, file, prosecute and
maintain all Collaboration Intellectual Property throughout the world. In furtherance of the
foregoing, Duramed shall be responsible for the conduct of any interference proceedings related to
any Collaboration Patent. Except as provided below, Duramed shall be responsible for all Patent
Expenses incurred throughout the world. Subject to the following sentence, should Duramed elect
not to prepare and/or file any such Collaboration Patent in the Shire Territory, it shall (a)
provide Shire with written notice as soon as reasonably possible after making such election but in
any event no later than [*] before Shire would be faced with a possible loss of rights, (b) give
Shire the right, at Shire’s discretion and expense, to prepare, file, prosecute or maintain the
Collaboration Patent in Duramed’s name, and (c) offer reasonable assistance in connection with such
preparation, filing, prosecution or maintenance. In the event Duramed determines in its sole
discretion, acting in good faith, to maintain certain Collaboration Intellectual Property as a
trade secret, Duramed shall have no obligation under the previous sentence.

     12.3 Cooperation. The Parties agree to cooperate in the preparation, filing, prosecution and
maintenance of all Patents under this ARTICLE 12, including obtaining and executing necessary
powers of attorney and assignments by the named inventors, providing relevant technical reports to
the filing Party concerning the Invention disclosed in such Patent, obtaining execution of such
other documents which shall be needed in the filing and prosecution of such Patent, and, as
requested, updating each other regarding the status of such Patent, and shall cooperate with the
other Party so far as reasonably necessary with respect to furnishing all information and data in
its possession reasonably necessary to obtain or maintain such Patents.

     12.4 Enforcement and Defense of Patents.

          12.4.1 Infringement of Third Party Patents.

               (a) Third Party Claims; Third Party Royalties. In the event of a Third Party Claim against
Shire, Duramed or their respective Affiliates alleging that the making, using, importing, selling
or offering to sell a Collaboration Product infringes or shall infringe claims in any patents of a
Third Party, the Party first obtaining knowledge of such Third Party Claim shall immediately
provide the other Party notice of such Third Party Claim with the related facts in reasonable
detail. Shire shall have the sole right to control such defense with respect to any Collaboration
Product with an attorney of Shire’s choice if the alleged infringing activity relates solely to the
Shire Territory. In such case, Duramed shall have the right to be

22

 

represented by independent counsel at Duramed’s own expense. Duramed shall have the sole
right to control such defense with respect to any Collaboration Product with an attorney of
Duramed’s choice if the alleged infringing activity relates solely to the Duramed Territory. In
such case, Shire shall have the right to be represented by independent counsel at Shire’s own
expense. If the alleged infringing activity relates to both the Duramed Territory and the Shire
Territory, then the Parties shall have the joint right, but not the obligation, to control such
defense with respect to Collaboration Product with an attorney of their mutual agreement. If the
Parties are unable to agree on such joint defense, then the Parties shall use good faith efforts to
determine the Party to assume control of such defense and choice of counsel. In such case, the
other Party shall have the right to be represented by independent counsel at its own expense. If,
as a result of a judgment in any litigation or settlement with a Third Party, either Party or its
Affiliates is required to pay royalties to any Third Party, such Party shall bear all cost of such
royalties.

               (b) Cooperation. If a Party shall become engaged in or participate in any suit described in
this Section 12.4.1, the other Party shall cooperate, and shall cause its and its Affiliates’
employees to cooperate, with such Party in all reasonable respects in connection therewith,
including giving testimony and producing documents lawfully requested, and using its reasonable and
diligent efforts to make available to the other, at no cost to the other (other than reimbursement
of actually incurred, reasonable out-of-pocket travel and lodging expenses), such employees who may
be helpful with respect to such suit, investigation, claim, interference or other proceeding.

          12.4.2 Prosecution of Infringers.

               (a) Notice. If either Party learns that a Third Party is infringing or allegedly infringing
any Collaboration Intellectual Property, or if any Third Party claims that any Collaboration
Intellectual Property is invalid or unenforceable, it shall promptly notify the other Party thereof
including available evidence of infringement or the claim of invalidity or unenforceability. The
Parties shall cooperate and use reasonable efforts to stop such alleged infringement or to address
such claim without litigation.

               (b) Enforcement and Defense.

               (i) [*] to take the appropriate steps to enforce or defend any Collaboration
Intellectual Property [*], and will have the [*] to take the appropriate steps to
enforce or defend any Collaboration Intellectual Property [*]. [*] may take steps
including the initiation, prosecution and control any suit, proceeding or other
legal action by counsel of its own choice. [*] for the costs of such enforcement or
defense. Notwithstanding the foregoing, [*], to be[*].

               (ii) If, pursuant to Section 12.4.2(b)(i), [*] take the appropriate steps to
enforce or defend any Collaboration Patent [*] of the date one Party has provided
notice to the other Party pursuant to Section 12.4.2(a) of such infringement or
claim, then [*], to bring any such suit, action or proceeding by counsel of its own
choice and [*], to be [*].

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               (c) Cooperation; Damages.

               (i) If one Party brings any suit, action or proceeding under this Section
12.4.2, the other Party agrees to be joined as party plaintiff if necessary to
prosecute the suit, action or proceeding and to give the first Party reasonable
authority to file and prosecute the suit, action or proceeding; provided, however,
that neither Party shall be required to transfer any right, title or interest in or
to any property to the other Party or any other party to confer standing on a Party
hereunder.

               (ii) The Party not pursuing the suit, action or proceeding hereunder shall
provide reasonable assistance to the other Party, including by providing access to
relevant documents and other evidence and making its employees available, subject to
the other Party’s reimbursement of any out-of-pocket expenses incurred by the
non-enforcing or defending Party in providing such assistance.

               (iii) Neither Party shall settle or otherwise compromise any such suit, action
or proceeding in a way that adversely affects the other Party’s intellectual
property rights or its rights or interests with respect to the Collaboration Product
without such Party’s prior written consent.

               (iv) Any settlements, damages or other monetary awards (the “Recovery”)
recovered pursuant to a suit, action or proceeding brought pursuant to Section
12.4.2 shall be allocated first to the costs and expenses of the Party taking such
action, and second, to the costs and expenses (if any) of the other Party, with any
remaining amounts (if any) with respect to a country in the Duramed Territory or the
Shire Territory to be allocated to Duramed or Shire, respectively.

     12.5 Notice of Certification. Duramed and Shire each shall immediately give notice to the
other of any certification filed under the U.S. Drug Price Competition and Patent Term Restoration
Act of 1984 (or its foreign equivalent) claiming that a Collaboration Patent, is invalid or that
infringement of a Collaboration Patent, shall not arise from the manufacture, use, offer for sale,
sale or importation product by a Third Party. Nothing in this Section 12.5 shall prevent or
otherwise limit Duramed’s right to take any and all such actions with regard to the matters
described in this Section 12.5 as required by applicable Law.

     12.6 Patent Term Extensions. Duramed and Shire shall cooperate in good faith in gaining
patent term extensions due to delay(s) in Regulatory Approval wherever applicable to the
Collaboration Patents. However, [*] in determining which Collaboration Patent(s) to [*] compound,
composition, article, product, process, or use. Should [*] that a [*] for a Collaboration Patent
and [*] of such Collaboration Patent, it shall (a) provide [*] as soon as reasonably possible [*]
but in [*], (b) give [*] Collaboration Patent in [*], and (c) offer reasonable assistance in
connection with such extension.

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     12.7 Trademarks and Copyrights.

          12.7.1 Product Trademarks. All Collaboration Products shall be marketed and sold worldwide
under and in connection with trademarks, trade dress, logos and slogans selected in accordance with
this Section 12.7.

          12.7.2 Trademark Selection. Duramed shall have the right and responsibility to select and
register trademarks, trade dress, logos and slogans for each Collaboration Product for use in the
Duramed Territory. Shire shall have the right and responsibility to select and register
trademarks, trade dress, logos and slogans for each Collaboration Product for use in the Shire
Territory; provided, that Shire may determine to use a Duramed Mark (as defined below) in
connection therewith as further set below in Section 12.7.3.

          12.7.3 Ownership of Trademarks. Duramed shall own, throughout the world, any trademarks,
trade dress, logos and/or slogans, and all registrations therefor, used or intended to be used for
a Collaboration Product which Duramed owns as of the Effective Date or that is otherwise selected
and/or registered by Duramed for use in connection with Collaboration Products (collectively, the
“Duramed Marks”). Shire shall own, throughout the world, any trademark, trade dress, logo and/or
slogans, and all registrations therefor, selected and/or registered by Shire for use in connection
with Collaboration Products (collectively, the “Shire Marks”). All goodwill attributable to a
Duramed Mark generated by the Commercialization of a Collaboration Product bearing a Duramed Mark
shall inure to the benefit of Duramed. All goodwill attributable to a Shire Mark generated by the
Commercialization of a Collaboration Product bearing a Shire Mark shall inure to the benefit of
Shire. Shire shall not use and/or register any Duramed Marks in the Shire Territory without the
prior consent of Duramed. Duramed shall not use and/or register any Shire Marks in the Duramed
Territory without the prior consent of Shire, provided, however, that if Shire determines to use a
Duramed Mark for the Commercialization of a Collaboration Product in the Shire Territory, Duramed
shall grant to Shire, a non-exclusive, royalty-free license, with the right to grant sublicenses,
to use such Duramed Mark in the Shire Territory, solely in conjunction with the Commercialization
of the Collaboration Products. Shire shall comply with Duramed’s then-current guidelines for
trademark usage, a copy of which shall be provided to Shire from time to time, in connection with
Shire’s use of such Duramed Mark. Duramed shall solely bear all costs of prosecution of
applications to register and to record licenses (if applicable) for, and maintenance of, each
Duramed Mark for each Collaboration Product. Shire shall solely bear all costs of prosecution of
applications to register and to record licenses (if applicable) for, and maintenance of, each Shire
Mark for each Collaboration Product, and any Duramed Marks that Shire elects to use in accordance
with the provisions of this Section 12.7.3 within the Shire Territory. Duramed shall cooperate
with Shire as reasonably requested by Shire in order to register (in Duramed’s name) any Duramed
Marks licensed to Shire under this Section 12.7.3 in the Shire Territory.

     12.8 Enforcements of Trademarks.

               (a) Notice. If either Party learns that a Third Party is infringing or allegedly infringing
any Duramed Marks of Shire Marks, or if any Third Party claims that any Duramed Marks of Shire
Marks is invalid or unenforceable, it will promptly notify the other Party thereof including
available evidence of infringement or the claim of invalidity or

25

 

unenforceability. The Parties will cooperate and use reasonable efforts to stop such alleged
infringement or to address such claim without litigation.

               (b) Enforcement and Defense. Duramed will have the first right (but not the obligation) to
take the appropriate steps to enforce or defend any Duramed Marks throughout the world, and will
have the exclusive right (but not the obligation) to take the appropriate steps to enforce or
defend any Duramed Marks in the Duramed Territory. Duramed may take steps including the
initiation, prosecution and control any suit, proceeding or other legal action by counsel of its
own choice. Duramed will be solely responsible for the costs of such enforcement or defense.
Notwithstanding the foregoing, Shire will have the right, at its own expense, to be represented in
any such action by counsel of its own choice. Shire will have the exclusive right (but not the
obligation) to take the appropriate steps to enforce or defend any Shire Marks in the Shire
Territory.

               (c) If, pursuant to Section 12.8(a), Duramed fails to take the appropriate steps to enforce or
defend any Duramed Marks within the Shire Territory within [*] of the date one Party has provided
notice to the other Party pursuant to Section 12.8(a) of such infringement or claim, then Shire
will have the right (but not the obligation), at its own expense, to bring any such suit, action or
proceeding by counsel of its own choice and Duramed will have the right, at its own expense, to be
represented in any such action by counsel of its own choice.

               (d) Cooperation; Damages.

               (i) If one Party brings any suit, action or proceeding under this Section 12.8,
the other Party agrees to be joined as party plaintiff if necessary to prosecute the
suit, action or proceeding and to give the first Party reasonable authority to file
and prosecute the suit, action or proceeding; provided, however, that neither Party
will be required to transfer any right, title or interest in or to any property to
the other Party or any other party to confer standing on a Party hereunder.

               (ii) The Party not pursuing the suit, action or proceeding hereunder will
provide reasonable assistance to the other Party, including by providing access to
relevant documents and other evidence and making its employees available, subject to
the other Party’s reimbursement of any out-of-pocket expenses incurred by the
non-enforcing or defending Party in providing such assistance.

               (iii) Neither Party will settle or otherwise compromise any such suit, action
or proceeding in a way that adversely affects the other Party’s intellectual
property rights or its rights or interests with respect to the Duramed Marks of
Shire Marks without such Party’s prior written consent.

               (iv) Any Recovery recovered pursuant to a suit, action or proceeding brought
pursuant to this Section 12.8 will be allocated first to the costs and expenses of
the Party taking such action, and second, to the costs and expenses (if any) of the
other Party, with any remaining amounts (if any) with

26

 

respect to a country in the Duramed Territory or the Shire Territory to be
allocated to Duramed or Shire, respectively.

          12.9 Costs of Defense. All of the unrecovered costs, expenses and legal fees (including
internal costs, expenses and legal fees) incurred by the Parties in bringing, maintaining and
prosecuting any action to maintain, protect or defend the Duramed Marks or Shire Marks shall be
borne by the Party bringing, maintaining or prosecuting the relevant action.

ARTICLE 13

REPRESENTATIONS AND WARRANTIES; EXCLUSIVITY

     13.1 Mutual Representations and Warranties. Each of the Parties hereby represents and
warrants to the other Party that, as of the date hereof:

               (a) Such Party has full corporate right, power and authority to enter into this Agreement and
to perform its respective obligations under this Agreement and that it has the right to grant the
rights and licenses granted pursuant to this Agreement.

               (b) This Agreement is a legal and valid obligation binding upon such Party and enforceable in
accordance with its terms. The execution, delivery and performance of the Agreement by such Party
does not conflict with any agreement, instrument or understanding, oral or written, to which it is
a Party or by which it is bound, nor violate any Law of any Governmental Authority having
jurisdiction over it.

               (c) Such Party has not granted any right to any Third Party that would conflict with the
rights granted to the other Party hereunder.

               (d) Such Party has obtained all necessary consents, approvals and authorizations of all
Government Authorities and other Persons required to be obtained by it as of the Effective Date in
connection with the execution, delivery and performance of this Agreement.

          13.2 Mutual Covenants. Each Party hereby covenants to the other Party that, during the Term:

               (a) Such Party shall not grant any right to any Third Party that would conflict with the
rights granted to the other Party hereunder;

               (b) In the course of Development hereunder, such Party shall not use any employee or
consultant that, to such Party’s knowledge, is debarred by the FDA (or any foreign equivalent) or
is the subject of debarment proceedings by the FDA (or any foreign equivalent).

          13.3 Duramed Representations and Warranties. Duramed hereby represents and warrants to Shire
that, as of the date hereof:

               (a) There is no action or proceeding pending or, to Duramed’s knowledge, threatened, with
respect to any existing Collaboration Product and/or the Ring

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Intellectual Property (excluding ordinary course patent prosecution activities before the U.S.
Patent and Trademark Office and equivalent foreign counterparts and Regulatory Authorities). There
are no material unsatisfied judgments or outstanding orders, injunctions, decrees, stipulations or
awards (whether rendered by a court, an administrative agency or by an arbitrator) against Duramed
or its Affiliates with respect to existing Collaboration Products and/or the Ring Product.

               (b) Attached hereto as Schedule 13.3(b) is a true, correct and complete list of all
INDs (including the INDs referenced in the preceding sentence) and Drug Approval Applications filed
with a Governmental Authority relating to Collaboration Products (together, the “Collaboration
Product INDs”) and all Collaboration Product INDs are and remain in effect.

               (c) Intellectual Property.

               (i) The Collaboration Intellectual Property includes the Patents set forth in
Schedule 13.3(c). Such schedules contain, where relevant for the Shire Territory,
all application numbers and filing dates, registration numbers and dates and
jurisdiction.

               (ii) Duramed has a good faith belief that the Collaboration Intellectual
Property may be configured into a commercial vaginal or cervical ring product,
either directly or through Development, that does not infringe the intellectual
property rights of any Third Party.

               (iii) Duramed has the right to grant to Shire the licenses set forth in this
Agreement, free of any rights, encumbrances or claims of any Third Party and without
payment by Shire of any royalties, license fees or other amounts to any Third Party.

               (iv) All Patents included in the Ring Intellectual Property are subsisting and,
to Duramed’s knowledge, valid, enforceable and inventorship thereof is properly
identified therein. None of such Patents is currently involved in any interference,
reissue, reexamination, or opposition proceeding, and neither Duramed nor any of its
Affiliates has received any written notice from any person, or has knowledge, of
such actual or threatened proceeding.

               (v) To Duramed’s knowledge, there is no unauthorized infringement by a Third
Party of Patents included in the Ring Intellectual Property.

               (d) Compliance with Law.

               (i) To Duramed’s knowledge, Duramed, its Affiliates and any Third Party to
which Duramed or its Affiliates have subcontracted activities in connection with
Compound and existing Collaboration Products, and the Ring Product have, complied
with all applicable Laws, permits, governmental licenses, registrations, approvals,
concessions, franchises, authorizations, orders,

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injunctions and decrees, including the Act, in the research, Development,
Manufacture and use thereof, and have not received any written notice from any
Governmental Authority claiming that any such activities as conducted by them are
not in such compliance.

               (ii) No Governmental Authority has commenced or, to Duramed’s knowledge,
threatened to initiate any action to reject or withdraw the Collaboration Product
INDs, or commenced or, to Duramed’s knowledge, threatened to initiate any action to
enjoin production of Collaboration Products at any facility, nor has Duramed or any
of its Affiliates or, to the knowledge of Duramed, any of its Contractors, received
any notice to such effect.

               (iii) Duramed has delivered or otherwise made available to Shire copies of all
substantive or material (A) reports of FDA Form 483 inspection observations, (B)
establishment inspection reports, (C) warning letters, and (D) other documents that
assert ongoing lack of compliance in any material respect with any applicable Laws
(including those of the FDA), in each case to the extent received by Duramed or any
of its Affiliates or, to the knowledge of Duramed, any of its contractors from the
FDA relating to a Collaboration Product and/or Compound, or the Ring Product.
Neither Duramed nor any of its Affiliates has received any such reports, letters or
other documents from any other Governmental Authority relating to a Collaboration
Product and/or the Ring Product.

               (iv) To Duramed’s knowledge, in the course of the Development of the
Collaboration Products or the Ring Intellectual Property, Duramed has not used any
employee or consultant that is debarred by the FDA or is the subject of debarment
proceedings by the FDA.

     13.4 Performance by Affiliates/Third Parties. Either Party may retain Affiliates and/or Third
Parties to perform Development and Commercialization activities under this Agreement. Each Party
shall remain responsible for and be guarantor of the performance by its Affiliates and Third
Parties and shall cause its Affiliates and Third Parties to comply with the provisions of this
Agreement in connection with such performance. Each Party hereby expressly waives any requirement
that the other Party exhaust any right, power or remedy, or proceed against an Affiliate or Third
Party, for any obligation or performance hereunder prior to proceeding directly against such Party.
Wherever in this Agreement the Parties delegate responsibility to Affiliates, Third Parties or
local operating entities, the Parties agree that such entities may not make decisions inconsistent
with this Agreement, amend the terms of this Agreement or act contrary to its terms in any way.

     13.5 Disclaimer of Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS ARTICLE 13,
DURAMED AND SHIRE MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN
FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND DURAMED AND SHIRE EACH SPECIFICALLY
DISCLAIMS ANY OTHER REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR
IMPLIED,

29

 

INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE.

     13.6 Limitation of Liability. EXCEPT FOR ANY BREACHES OF SECTIONS 6.3 AND 6.4, IN NO EVENT
SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN ANY WAY OUT OF
THIS AGREEMENT. THE FOREGOING LIMITATIONS SHALL NOT LIMIT EITHER PARTY’S OBLIGATIONS TO THE OTHER
PARTY FOR INDEMNIFICATION OF THIRD PARTY CLAIMS UNDER ARTICLE 15.

ARTICLE 14

TERM AND TERMINATION

     14.1 Term. This Agreement shall commence as of the Effective Date and, unless sooner
terminated as provided herein, shall expire on the later of (i) the last Valid Claim contained in
any Collaboration Patent or (ii) the date when Shire and its Affiliates cease selling the last of
its Collaboration Products, but in any event not before eight (8) years after the Effective Date
(the “Term”).

     14.2 Termination for Material Breach. Either Party (the “Notifying Party”) may terminate this
Agreement on a Collaboration Product-by-Collaboration Product basis at any time in the event the
other Party (the “Breaching Party”) has materially breached this Agreement with respect to such
Collaboration Product and, if the material breach is capable of cure, such material breach
continues uncured for a period of ninety (90) days after written notice thereof by the Notifying
Party; provided, however, in the event that the Breaching Party has in good faith commenced cure
within such ninety (90) day period, but cannot practically complete such cure within such ninety
(90) day period, the Breaching Party shall have an additional ninety (90) day cure period. In the
event a material breach is incapable of cure, without limiting any other rights of the Notifying
Party, including the right to seek injunctive relief, the non-Breaching Party shall not have the
right to terminate this Agreement on a Collaboration Product-by-Collaboration Product basis if (i)
the Breaching Party is providing full cooperation to mitigate the breach, and (ii) the breach was
not caused by willful misconduct by the Breaching Party.

     14.3 Termination of Commercialization by Shire.

          14.3.1 [*]. Shire may elect to cease Development or Commercialization of any Collaboration
Product for the Shire Territory at any time in the Shire Territory (such Collaboration Product, to
the extent of the ceased Development activities, the “Ceased Collaboration Product”). In such
event Shire shall promptly notify Duramed thereof, and offer Duramed the right to repurchase the
Ceased Collaboration Product on terms to be mutually agreed. Without limiting the previous
sentence, if at any time [*] under this Agreement [*] Ceased Collaboration Product [*]
Collaboration Product, [*] that are the subject [*] upon the [*], including the [*], to be [*]. If
[*], or [*] after receipt of [*], whichever occurs first, then [*] on such terms and conditions
that, [*].

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     14.4 Upon Termination. Termination of this Agreement shall not affect the obligation of any
Party to pay the other Party any amounts due hereunder accrued prior to the termination date
hereof. The right to terminate this Agreement shall not prejudice any other right or remedy in
equity or at Law of a Party in respect of any breaches of this Agreement. Upon termination of this
Agreement by Duramed, all worldwide rights to Commercialize the Collaboration Products shall revert
to Duramed. Upon termination by Duramed with the exception of one copy which Shire shall keep for
its internal business purposes, Shire shall promptly transfer any materials, information, books and
records, and data in its possession relating to Development, Commercialization or to Regulatory
Approvals of the Collaboration Products, together with any other books and records of Duramed made
available to Shire in furtherance of the transactions contemplated hereby.

     14.5 Survival. The provisions of Sections 8.4, 12.1, 13.6, 14.4, and 14.5, and Articles X,
XI, XV, XVI and XVII shall survive [*] this Agreement.

ARTICLE 15

INDEMNIFICATION; INSURANCE

     15.1 Indemnification.

          15.1.1 Indemnification by Shire. Shire hereby agrees to hold Duramed, its Affiliates, and
their respective directors, agents and employees harmless from and against any and all Losses
arising in connection with any and all charges, complaints, actions, suits, proceedings, hearings,
investigations, claims, demands, judgments, orders, decrees, stipulations or injunctions by a Third
Party (each a “Third Party Claim”) resulting directly from (a) any breach by Shire of any of its
representations, warranties, covenants or obligations pursuant to this Agreement, (b) the
negligence or willful misconduct by Shire or its Affiliates or their respective officers,
directors, employees, agents or consultants in performing any obligations under this Agreement, (c)
use, handling, storage, sale or other disposition of Collaboration Products (including, without
limitation, those Third Party Claims that involve death or bodily injury (or allegations thereof)
to any individual or any property other than intellectual property) arising out of activities
conducted by or on behalf of Shire or related to the Shire Territory, or (d) the conduct of
clinical testing of the Collaboration Products by or on behalf of Shire, except for such matters as
Duramed is obligated to indemnify Shire under Section 15.1.2; in each case except to the extent
that such Losses result from the negligence or willful misconduct of Duramed.

          15.1.2 Indemnification by Duramed. Duramed hereby agrees to hold Shire, its Affiliates, and
their respective directors, agents and employees harmless from and against any and all Losses
arising in connection with any and all Third Party Claims resulting directly from (a) any breach by
Duramed of any of its representations, warranties, covenants or obligations pursuant to this
Agreement, (b) the negligence or willful misconduct by Duramed or its Affiliates or their
respective officers, directors, employees, agents or consultants in performing any obligations
under this Agreement, (c) manufacture, use, handling, storage, sale or other disposition of
Collaboration Products (including, without limitation, those Third Party Claims that involve death
or bodily injury (or allegations thereof) to any individual or any property other than intellectual
property) arising out of activities conducted by or on behalf of Duramed or related to the Duramed
Territory, (d) the conduct of clinical testing of the Collaboration Products

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by or on behalf of Duramed, or (e) Duramed’s (or its agent’s, contractor’s or other
designee’s, other than Shire) failure to comply with cGMP, applicable product specifications or
applicable Law in connection with the Manufacture of Collaboration Product supplied to Shire
hereunder; in each case except to the extent that such Losses result from the negligence or willful
misconduct of Shire.

     15.1.3 The rights of indemnification under this Section 15.1 shall be subject to the
provisions of Sections 15.2 through 15.8.

     15.2 Notice of Claim. All indemnification claims in respect of any indemnitee seeking
indemnity under Section 15.1 (collectively, the “Indemnitees” and each an “Indemnitee”) shall be
made solely by the corresponding Party (the “Indemnified Party”). The Indemnified Party shall give
the indemnifying Party (the “Indemnifying Party”) prompt written notice (an “Indemnification Claim
Notice”) of any Losses or the discovery of any fact upon which such Indemnified Party intends to
base a request for indemnification under Section 15.1, but in no event shall the Indemnifying Party
be liable for any Losses that result from any delay in providing such notice which materially
prejudices the defense of such Third Party Claim. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to the extent that the nature and
amount of such Loss are known at such time). Together with the Indemnification Claim Notice, the
Indemnified Party shall furnish promptly to the Indemnifying Party copies of all notices and
documents (including court papers) received by any Indemnitee in connection with the Third Party
Claim. The Indemnifying Party shall not be obligated to indemnify the Indemnified Party to the
extent any admission or statement made by the Indemnified Party materially prejudices the defense
of such Third Party Claim.

     15.3 Control of Defense. At its option, the Indemnifying Party may assume the defense of any
Third Party Claim subject to indemnification as provided for in Sections 15.1.1 and 15.1.2 by
giving written notice to the Indemnified Party within [*] after the Indemnifying Party’s receipt of
an Indemnification Claim Notice. Upon assuming the defense of a Third Party Claim, the
Indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal
counsel it selects. Should the Indemnifying Party assume the defense of a Third Party Claim, the
Indemnifying Party shall not be liable to the Indemnified Party or any other Indemnitee for any
legal expenses subsequently incurred by such Indemnified Party or other Indemnitee in connection
with the analysis, defense or settlement of the Third Party Claim.

     15.4 Right to Participate in Defense. Without limiting Section 15.3, any Indemnitee shall be
entitled to participate in, but not control, the defense of a Third Party Claim for which it has
sought indemnification hereunder and to employ counsel of its choice for such purpose; provided,
however, that such employment shall be at the Indemnitee’s own expense unless (a) the employment
thereof has been specifically authorized by the Indemnifying Party in writing, or (b) the
Indemnifying Party has failed to assume the defense and employ counsel in accordance with Section
15.3 (in which case the Indemnified Party shall control the defense).

     15.5 Settlement. With respect to any Losses relating solely to the payment of money damages
in connection with a Third Party Claim and that shall not result in the Indemnitee’s becoming
subject to injunctive or other relief or otherwise adversely affect the business of the Indemnitee
in any manner, and as to which the Indemnifying Party shall have acknowledged in

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writing the obligation to indemnify the Indemnitee hereunder, the Indemnifying Party shall
have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Loss, on such terms as the Indemnifying Party, in its reasonable discretion, shall
deem appropriate (provided, however that such terms shall include a complete and unconditional
release of the Indemnified Party from all liability with respect thereto), and shall transfer to
the Indemnified Party all amounts which said Indemnified Party shall be liable to pay prior to the
time of the entry of judgment. With respect to all other Losses in connection with Third Party
Claims, where the Indemnifying Party has assumed the defense of the Third Party Claim in accordance
with Section 15.3, the Indemnifying Party shall have authority to consent to the entry of any
judgment, enter into any settlement or otherwise dispose of such Loss provided it obtains the prior
written consent of the Indemnified Party (which consent shall be at the Indemnified Party’s
reasonable discretion). The Indemnifying Party that has assumed the defense of the Third Party
Claim in accordance with Section 15.3 shall not be liable for any settlement or other disposition
of a Loss by an Indemnitee that is reached without the written consent of such Indemnifying Party.
Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim,
no Indemnitee shall admit any liability with respect to, or settle, compromise or discharge, any
Third Party Claim without first offering to the Indemnifying Party the opportunity to assume the
defense of the Third Party Claim in accordance with Section 15.3.

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

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

     15.8 Treatment of Certain Losses. Duramed shall be solely responsible for all Losses from
Third Party Claims resulting directly from the use or administration of the Compounds,
Collaboration Products prior to the Effective Date.

     15.9 Insurance. Each Party shall obtain and keep in force, through self insurance or
otherwise, in a form reasonably acceptable to the other Party hereto, insurance in scope and amount
as required by Law applicable to a Party’s activities hereunder and such additional

33

 

amounts as may be reasonably necessary to cover such Party’s indemnity obligations under this
Agreement with scope and coverage as is normal and customary in the biotechnology/pharmaceutical
industry generally for parties similarly situated. It is understood that such insurance shall not
be construed to limit a Party’s liability with respect to its indemnification obligations under
this ARTICLE 15. Each Party shall, except to the extent self insured, provide to the other Party
upon request a certificate evidencing the insurance such Party is required to obtain and keep in
force under this ARTICLE 15.

     15.10 Guaranty. In consideration of [*] under this Agreement, and to induce [*] to enter into
this Agreement, [*] under this Agreement, in accordance with the terms and conditions of this
Agreement, [*] under this Agreement in accordance with its terms.

ARTICLE 16

DISPUTE RESOLUTION

     16.1 Disputes. The Parties hereby agree that all disputes arising under this Agreement shall
be referred to a senior executive of Duramed and a senior executive of Shire (the
“Representatives”). If any such matter has not been resolved within [*] of such referral to the
Representatives either Party may invoke the provisions of Section 16.2 for such dispute. No
dispute resolution procedure set forth in this Agreement shall be construed as an agreement to
arbitrate under any federal or state arbitration Law, including but not limited to the Federal
Arbitration Act, and shall not deprive a court of competent jurisdiction from resolving any dispute
arising under, or related to, this Agreement.

     16.2 Litigation. Any dispute that is not resolved as provided in the preceding Section 16.1,
whether before or after termination of this Agreement, may be submitted by either Party only to any
court of competent jurisdiction. This Agreement shall be governed by, and construed in accordance
with, the Laws of the State of New York. The Parties unconditionally and irrevocably agree and
consent to the exclusive jurisdiction of the courts located in New York, NY and waive any objection
with respect thereto, for the purpose of any action, suit or proceeding arising out of or relating
to this Agreement or the transactions contemplated hereby and further agree not to commence any
such action, suit or proceeding except in any such court.

     16.3 Injunctive Relief. Notwithstanding anything to the contrary in this Agreement, either
Party shall have the right to seek temporary injunctive relief in any court of competent
jurisdiction as may be available to such Party under the Laws and rules applicable in such
jurisdiction with respect to any matters arising out of the other Party’s performance of its
obligations under this Agreement.

ARTICLE 17

MISCELLANEOUS

     17.1 Entire Agreement; Amendment. This Agreement, including the exhibits attached hereto and
thereto (each of which is hereby and thereby incorporated herein and therein by reference), sets
forth the complete, final and exclusive agreement and all the covenants, promises, agreements,
warranties, representations, conditions and understandings between the Parties hereto and
supersedes and terminates all prior agreements and understandings between

34

 

the Parties, which shall continue to govern the obligations of the Parties with respect to
information disclosed thereunder with respect to periods prior to the Effective Date. There are no
covenants, promises, agreements, warranties, representations, conditions or understandings, either
oral or written, between the Parties other than as are set forth herein. No subsequent alteration,
amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to
writing and signed by an authorized officer of each Party. For the avoidance of doubt, the
Parties agree that all covenants, promises, agreements, warranties, representations, conditions,
and understandings set forth herein are made and deemed effective as of the Effective Date, and
that the execution of this Agreement shall not constitute a waiver of any right or claim of either
Party as of the Effective Date.

     17.2 Force Majeure. Each Party shall be excused from the performance of its obligations under
this Agreement to the extent that such performance is prevented by force majeure and the
nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse
shall be continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition. For purposes of this
Agreement, force majeure shall include conditions beyond the control of the Parties, including
without limitation, an act of God, voluntary or involuntary compliance with any regulation, Law or
order of any government, war, civil commotion, labor strike or lock-out, epidemic, failure or
default of public utilities or common carriers, destruction of production facilities or materials
by fire, earthquake, storm or like catastrophe; provided, however, the payment of invoices due and
owing hereunder shall not be delayed by the payer because of a force majeure affecting the payer,
unless such force majeure specifically precludes the payment process.

     17.3 Notices. All notices or other communications that are required or permitted under this
Agreement shall be in writing and delivered personally, sent by facsimile (and promptly confirmed
by personal delivery or overnight courier as provided in this Agreement), or sent by
internationally-recognized overnight courier to the addresses below. Any such communication shall
be deemed to have been given (a) when delivered, if personally delivered or sent by facsimile on a
Business Day (so long as promptly confirmed by personal delivery or overnight courier as provided
in this Agreement), and (b) on the second Business Day after dispatch, if sent by
internationally-recognized overnight courier. Unless otherwise specified in writing, the mailing
addresses of the Parties shall be as described below.

	 	 	 	 	 
	 

	 	For Duramed:
	 	Duramed Pharmaceuticals, Inc.
	 

	 	400 Chestnut
	 	Ridge Road
	 

	 	 	 	Woodcliff Lake, NJ 07677
	 

	 	 	 	Phone: 201-930-3300
	 

	 	 	 	Fax: 201-930-3330
	 

	 	 	 	Attention: President
	 
	 	 	 	 
	 

	 	with a copy to:
	 	Barr Pharmaceuticals, Inc.
	 

	 	 	 	400 Chestnut Ridge Road
	 

	 	 	 	Woodcliff Lake, NJ 07677
	 

	 	 	 	Phone: 201-930-3300
	 

	 	 	 	Fax: 888-843-0563

35

 

	 	 	 	 	 
	 

	 	 	 	Attention: General Counsel
	 
	 	 	 	 
	 

	 	For Shire:
	 	Shire LLC
	 

	 	 	 	725 Chesterbrook Boulevard
	 

	 	 	 	Wayne, Pennsylvania 19087-5637
	 

	 	 	 	Fax: (484) 595-8163
	 

	 	 	 	Attention: General Counsel
	 
	 	 	 	 
	 

	 	with a copy to:
	 	Morgan, Lewis & Bockius LLP
	 

	 	 	 	502 Carnegie Center

Princeton, NJ 08540
	 

	 	 	 	Fax: (609) 919-6701
	 

	 	 	 	Attention: Randall B. Sunberg

     17.4 Independent Contractors. In making and performing this Agreement, Shire and Duramed
shall act at all times as independent contractors and nothing contained in this Agreement shall be
construed or implied for any purpose to create an agency, partnership, limited partnership, joint
venture or employer and employee relationship between Shire and Duramed and this Agreement shall
not be construed to suggest otherwise. At no time shall one Party make commitments or incur any
charges or expenses for or in the name of the other Party. Except as otherwise provided in this
Agreement, each Party shall be solely responsible for its own costs and expenses associated with
this Agreement.

     17.5 Non-Solicitation. From and after the Effective Date until the one (1) year anniversary
of the termination or expiration of this Agreement, neither Party shall, and shall cause each of
its Affiliates not to, directly or indirectly, without the other Party’s prior written consent,
solicit the employment of any employee (or former employee bound by a non-competition obligation)
of the other Party or its Affiliates with whom it has come in contact in conducting activities
under this Agreement; provided, however, that the foregoing provisions shall not apply to (a) a
general advertisement or solicitation program that is not specifically targeted at such persons or
(b) the solicitation of any employee after such time as such employee’s employment has been
terminated by the other Party or its Affiliate.

     17.6 Maintenance of Records. Each Party shall keep and maintain all records required by Law
with respect to Collaboration Products and shall make copies of such records available to the other
Party upon reasonable request.

     17.7 United States Dollars. References in this Agreement to “Dollars” or “$” shall mean the
legal tender of the United States.

     17.8 No Strict Construction. This Agreement has been prepared jointly and shall not be
strictly construed against either Party.

     17.9 Assignment. Neither Party shall sell, transfer, assign, delegate, pledge or otherwise
dispose of, whether voluntarily, involuntarily, by operation of Law or otherwise, this Agreement or
any of its rights or obligations under this Agreement without the prior written consent of the
other Party (which consent may be granted, withheld or conditioned at such other

36

 

Party’s sole and absolute discretion); provided, however, that either Party may assign or
transfer this Agreement or any of its rights or obligations under this Agreement without the
consent of the other Party to any Affiliate of such Party, or to any Third Party (a) with which it
merges or consolidates, or to which it transfers all or substantially all of its assets to which
this Agreement pertains or (b) subject to Section 14.3.1, in part, in connection with the sale or
transfer of such Party’s business relating to Commercialization of any Collaboration Product within
a particular country. The assigning Party (unless it is not the surviving entity) shall remain
jointly and severally liable with, and shall guarantee the performance of, the relevant Affiliate
or Third Party assignee under this Agreement, and the relevant Affiliate assignee, Third Party
assignee or surviving entity shall assume in writing all of the assigning Party’s obligations under
this Agreement. Notwithstanding the foregoing, in the event Duramed sells, transfers, assigns,
delegates, pledges, licenses or otherwise disposes of a Collaboration Product(s) to a Third Party
(whether pursuant to a joint venture, collaboration or otherwise), Shire shall have no obligation
to reimburse such Third Party for any development expenses such Third Party may incur with respect
to such Collaboration Product(s); provided, however, that Duramed shall remain entitled to
reimbursement pursuant to Section 7.2 for any remaining Collaboration Products up to the Maximum
Reimbursement Amount. Any purported assignment or transfer in violation of this Section 17.9 shall
be void ab initio and of no force or effect. Notwithstanding anything to the contrary herein, in
the event any assignment by Shire hereunder gives rise to any obligation to withhold any amounts
payable to Duramed, Shire, or its assignee, shall be entitled to deduct from all payments due under
this Agreement the amount of all applicable withholding taxes to the extent Shire, or its assignee,
pays such taxes to the appropriate governmental authority on behalf of Duramed. Shire shall
properly furnish Duramed with copies of tax receipts evidencing the payment of all such taxes,
levies and assessments. Duramed and Shire shall cooperate with each other in obtaining any
exemption from, a refund for, or reduced rate of tax available under any applicable law or tax
treaty. Notwithstanding the foregoing, Shire shall be liable for, and indemnify Duramed against,
any non-U.S. taxes, any value-added or sales taxes, any duties or levies and assessments, howsoever
designated or computed that are required to be paid or withheld by Shire on such payments. Shire
shall so indemnify Duramed within [*] of Shire’s receipt of notification from Duramed (in
accordance with Section 17.3 hereof) that either (i) based upon current facts and circumstances,
Duramed does not have or will not have during the applicable tax year any or sufficient foreign tax
credits available to utilize to offset such tax liability; or (ii) Duramed has applied for a refund
from the taxing authority at issue (such notice to include a copy of such refund application).
Notwithstanding anything in this Agreement to the contrary, in the event that withholding taxes are
paid on behalf of Duramed by Shire, if Duramed uses a foreign tax credit received as a result of
the payment of withholding taxes by Shire and thereby reduces the amount of U.S. income tax that
Duramed otherwise would have paid, or otherwise receives a refund, Duramed shall refund to Shire
the amount of such reduction with respect to such foreign tax credit or such refund.

     17.10 Counterparts. This Agreement may be executed in two counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and the same instrument.
Signatures provided by facsimile transmission shall be deemed to be original signatures.

37

 

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

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

     17.13 Headings. The headings for each article and section in this Agreement have been
inserted for convenience of reference only and are not intended to limit or expand on the meaning
of the language contained in the particular article or section.

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

[Signature Page Follows.]

38

 

     IN WITNESS WHEREOF, the Parties have executed this Collaboration and License Agreement in
duplicate originals by their proper officers as of the date first written above.

	 	 	 	 	 	 	 
	 	 	DURAMED PHARMACEUTICALS, INC.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Fred Wilkinson	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	Name Fred Wilkinson	 	 
	 

	 	 	 	Title  	 	 
	 
	 	 	 	 	 	 
	 	 	SHIRE LLC	 	 
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	Name Matthew Emmens	 	 
	 

	 	 	 	Title  CEO	 	 

	 	 	 	 	 	 	 
	 	 	SHIRE PLC (solely for purposes of Section 15.10)	 	 
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	Name Matthew Emmens	 	 
	 

	 	 	 	Title  CEO	 	 

[Signature Page to Product Development and License Agreement]

 

 

EXHIBIT A

INITIAL COLLABORATION PRODUCTS

Compound

[*]

[*]

[*]

[*]

[*]

 

 

EXHIBIT B

SUPPLY AGREEMENT

 

 

SUPPLY AGREEMENT

BETWEEN

SHIRE LLC

AND

DURAMED LABORATORIES, INC.

DATED AS OF

AUGUST 14, 2006

 

 

SUPPLY AGREEMENT

     This SUPPLY AGREEMENT (this “Agreement”), dated as of August 14, 2006, by and among
Shire LLC, a Kentucky limited liability company having a place of business at 725 Chesterbrook
Boulevard, Wayne, Pennsylvania 19087 (“Shire”), and Duramed Pharmaceuticals, Inc., a
Delaware corporation having a place of business at 400 Chestnut Ridge Road, Woodcliff Lake, NJ
07677 (“Duramed”) (each a “Party” and collectively, the “Parties”).

RECITALS

     WHEREAS, the Parties have entered into that certain Product Development and License Agreement
(the “Product Development Agreement”), dated as of the date hereof, pursuant to which the
Parties are developing Collaboration Products (as defined therein), with such Collaboration
Products to be commercialized by Duramed in certain geographic regions, and by Shire in the rest of
the world (capitalized terms used herein but not defined herein shall have the meanings set forth
in the Product Development Agreement);

     WHEREAS, the Product Development Agreement contemplates the Parties entering into this
Agreement to govern the supply of Collaboration Products by Duramed to Shire; and

     WHEREAS, Duramed desires to manufacture and/or supply the Collaboration Products to Shire upon
the terms and subject to the conditions of this Agreement.

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

ARTICLE I

DEFINITIONS

     “Affiliate” means, with respect to a Party, any entity that directly or indirectly
controls, is control led by, or is under common control with, such Party, but only for so long as
such control continues. For purposes of this definition, “control” means the power to direct the
management and affairs of an entity, directly or indirectly, whether through the ownership of
voting securities, by contract or otherwise. In the case of a corporation, the direct or indirect
ownership of fifty percent (50%) or more of its outstanding voting shares shall in any case be
deemed to confer control, provided that, the direct or indirect ownership of a lower percentage of
such securities shall not necessarily preclude the existence of control.

     “API Cost” for a Shire Product means the actual cost paid by Duramed on a pass-through
basis for the active pharmaceutical ingredient in such Shire Product. For the avoidance of doubt,
all raw material and manufacturing costs of cervical and vaginal rings in a Shire Product shall not
be included in the API Cost.

     “Changeover Plan” has the meaning set forth in Section 8.2.

 

 

     “Effective Date” means the date on which the Parties have attached mutually agreed
Exhibits to this Agreement for the supply of a particular Collaboration Product in accordance with
Section 2.1.

     “Force Majeure Event” has the meaning set forth in Section 9.1.

     “Fully Allocated Manufacturing Cost” means the actual cost incurred by Duramed for
Manufacturing Shire Product, calculated in accordance with GAAP and using normal standard cost
accounting and allocation methods and procedures of Duramed consistently applied and maintained,
including, but not limited to, API Cost, all raw material and manufacturing costs of cervical and
vaginal rings, and all costs of active and inactive ingredients therein; provided that, for
purposes of this Agreement, Fully Allocated Manufacturing Cost shall not include overhead
absorption related to significant idle or excess capacity in connection with (i) expansion of an
existing facility; or (ii) the construction or validation of any new manufacturing facility of
Duramed or any of its Affiliates that may be constructed after the date of this Agreement first
written above.

     “Losses” means any and all liabilities, damages, fines, penalties, deficiencies,
losses and expenses (including interest, court costs, amounts paid in settlement, reasonable fees
of attorneys, accountants and other experts or other reasonable expenses of litigation or other
proceedings or of any claim, default or assessment); provided, however, that the term “Losses”
shall not include any special, consequential, indirect, punitive or similar damages, except to the
extent actually paid by a Party pursuant to any Third Party Claim.

     “Manufacturing” shall mean all activities related to the manufacturing of a Shire
Product or any component or ingredient thereof, including packaging, in-process and finished
product testing, release of product or any component or ingredient thereof, quality assurance
activities related to manufacturing and release of product, ongoing stability tests and regulatory
activities related to any of the foregoing.

     “Net Sales Price” shall mean, [*]

     “Packaging Specifications” means the packaging and labeling specifications for Shire
Product set forth on Exhibit B, as amended or supplemented from time-to-time in accordance
with Section 3.13.

     “Product Specifications” means the specifications for Shire Product set forth on
Exhibit A, as amended or supplemented from time-to-time on mutual agreement of the Parties.

     “Purchase Order” has the meaning set forth in Section 3.2.

     “Rolling Forecast” has the meaning set forth in Section 3.1.

     “Shire Product” means a Collaboration Product to be manufactured hereunder as set
forth in Section 2.1.

     “Term” has the meaning set forth in Section 7.1.

2

 

     “Termination Assistance Services” has the meaning set forth in Section 8.1.

ARTICLE II

SUPPLY OF PRODUCTS

     Section 2.1. Collaboration Products. Pursuant to the terms and conditions of this
Agreement, Shire shall exclusively purchase from Duramed, and Duramed shall supply to Shire,
Shire’s requirements for Collaboration Products, including for Development activities under the
Product Development Agreement, in placebo and active forms. Upon Development of a Collaboration
Product under the Product Development Agreement, the Parties shall attach hereto mutually agreed
Exhibits applicable to the supply of such Collaboration Product. This Agreement, together with
such Exhibits, shall be considered a separate agreement for each Collaboration Product. Duramed
shall have no obligation to supply any Collaboration Product that has not been reduced to final
finished dosage form under the applicable Development Plan, and all Exhibits hereto shall be
consistent with such final finished dosage form.

     Section 2.2. Cooperation on Manufacturing Plan. The Parties acknowledge that Duramed
will require certain minimum lead times and may have various options for manufacturing Shire
Product hereunder, which options may include (i) building a dedicated manufacturing plant, which
plant may or may not include excess capacity, (ii) utilizing excess capacity at existing
manufacturing plants, (iii) expanding capacity at existing manufacturing plants, or (iv)
combinations of the foregoing. Within [*] following the Effective Date (with respect to each
Collaboration Product), the Parties shall meet to develop non-binding forecasts for capacity
planning purposes of Shire’s anticipated needs for each Shire Product for clinical and commercial
purposes over the clinical testing period and (i) the twelve (12) month period following first
commercial launch of each Shire Product; and (ii) the 36 month period following the first
commercial launch of each Shire Product. Thereafter, the Parties shall meet on an as-required
basis, but no less than once each calendar quarter, to update such capacity planning forecast. The
Parties shall also reasonably cooperate to develop non-infringing manufacturing techniques for
Collaboration Products.

     Section 2.3. Initial Forecast and Purchase Order. At least [*] prior to the first
anticipated clinical use or commercial launch for a Shire Product, Shire shall submit to Duramed an
initial forecast (the “Initial Forecast”), which Initial Forecast shall be updated
thereafter in accordance with Section 3.1. Notwithstanding any other provision of this Agreement,
in no event shall Shire submit a Purchase Order for any initial order of a Shire Product [*] prior
to the required delivery date for such initial order.

     Section 2.4. Initial Implementation Meeting. No later than thirty (30) days after the
receipt of an initial Purchase Order, Duramed and Shire shall hold an initial implementation
meeting (at such time and place or by such means as are mutually agreed by the Parties) to develop
specific implementation requirements for the supply of Shire Product to Shire. Thereafter, Duramed
and Shire shall conduct implementation-planning meetings as reasonably required by the Parties in
order to update and discuss (i) the current status of Duramed’s implementation activities, and
(iii) the status of any actual and anticipated problem areas, their impact on the work efforts of
Duramed, and actions being taken and/or needed to be taken by the Parties in order to reduce the
potential impact of such problems.

3

 

ARTICLE III

FORECASTS, ORDERS AND SHIPMENT

     Section 3.1. Forecasted Quantities. [*]

     Section 3.2. Purchase Order Form. Shire shall submit all orders for the purchase of
Shire Products using the form of purchase order attached hereto as Schedule 1 (each a
“Purchase Order”). Each Purchase Order will be delivered to such location as Duramed
designates in writing to Shire from time to time. After Duramed receives a Purchase Order, Duramed
shall acknowledge receipt thereof in writing within five (5) business days, either (i) accepting
the Purchase Order, or (ii) seeking clarification of the Purchase Order, if necessary. Duramed
shall have no obligation to accept any Purchase Order that does not include all information
required on Schedule 1 or that is inconsistent with the terms and conditions of this
Agreement. In the event that an order is rejected, Duramed and Shire will cooperate in good faith
to resolve any supply issues raised by such order. The minimum size of any order placed by Shire
will be a full batch in accordance with Exhibit A hereto.

     Section 3.3. Delivery of Shire Product. Upon acceptance of a Purchase Order, Duramed
shall deliver all Shire Product by the delivery date covered by such Purchase Order in accordance
with the terms of this Agreement and such Purchase Order, including the quantities accepted in each
Purchase Order. At the time of delivery to Shire, all Shire Product manufactured hereunder shall
meet the Product Specification applicable thereto in all material respects, and shall be finished,
packaged, labeled and/or ready for commercial sale by Shire as required in accordance with the
Packaging Specifications.

     Section 3.4. Expedited Delivery. Upon the request of Shire to supply the quantities
of Shire Product under a Purchase Order on an expedited basis, Duramed shall notify Shire of any
expected increased costs that Duramed anticipates it will incur. Subject to prior written approval
by Shire of these increased costs, Duramed shall use reasonable efforts to supply the quantities of
Shire Product on an expedited basis. Duramed shall not have any liability for any failure to meet
any such requested expedited delivery schedule.

     Section 3.5. Excess Purchase Orders. Duramed shall use commercially reasonable
efforts to, but shall not be obligated to supply quantities of any Shire Product in excess of 120%
of the quantities set forth in the most recent forecast for such quarter. If Duramed believes it
will be unable to deliver any additional volume on the date specified by Shire in the applicable
Purchase Order, Duramed shall notify Shire in writing as promptly as practicable, and shall provide
a proposed alternative delivery schedule. Any agreement on the delivery schedule for such
additional volume shall be documented in writing and shall become effective only upon mutual
written agreement of both Parties to the terms and conditions thereof.

     Section 3.6. Cancellation of Orders. Shire may not cancel an order without payment to
Duramed in full for the order. Duramed shall, in good faith, use commercially reasonable efforts
to mitigate the costs of cancellation of any Purchase Order.

     Section 3.7. Conflict. The terms of this Agreement shall prevail over any
conflicting, inconsistent or additional terms set forth in any Purchase Order.

4

 

     Section 3.8. Delivery and Risk of Loss. All Shire Products shipped under this
Agreement will be shipped Ex-Works (Incoterms 2000) Duramed’s manufacturing facility to such
location designated by Shire in the applicable accepted Purchase Order. Shire will pay all
freight, insurance charges, taxes, import and export duties, inspection fees and other charges
applicable to the sale and transport of Shire Products. Risk of loss to Shire Products shall pass
to Shire upon delivery to Shire’s designated carrier. Title to all Shire Products manufactured
hereunder shall pass to Shire on payment by Shire for the applicable Shire Product or pro-rata
portion thereof.

     Section 3.9. Certificate of Analysis. A Certificate of Analysis (“COA”) will
accompany each shipment of Shire Products in the form attached hereto as Schedule 2.

     Section 3.10. Location of Manufacturing. All Shire Products Shire shall be
manufactured in a facility that has been designated as an approved manufacturing facility by the
applicable Regulatory Approval for such Shire Product. Should Duramed desire to change any of the
manufacturing site for a Shire Product, or any component thereof, to a site other than those
designated in the applicable Regulatory Approval, Duramed shall notify Shire in writing and the
Parties shall thereafter meet to discuss the potential consequences of such a change. Duramed
shall not change manufacturing sites for any Shire Product, or any component thereof, except in
accordance with the authorization of the applicable Governmental Authority, and the procedures and
requirements set forth in this Agreement.

     Section 3.11. Shortage of Materials. In the event that the materials and/or resources
required to manufacture and deliver Shire Products to Shire in accordance with this Agreement are,
or are reasonably anticipated to become, in short supply such that Duramed may be unable to provide
Shire with the quantities of Shire Products set forth in a Purchase Order, Duramed shall notify
Shire of such shortage as promptly as practicable. If Duramed so notifies Shire, Duramed and Shire
shall promptly meet to discuss how to address the potential shortage. In the event that Duramed,
at any time, has any information indicating that it may not be able to supply Shire with all Shire
Products in accordance with a confirmed Purchase Order, Duramed shall as soon as practicable
provide Shire a written notice to that effect. To the extent that there is any such shortage,
Duramed shall allocate on a pro-rata basis the supply of Shire Products and similar Duramed
products based on the prior 12 months’ sales for each of Shire and Duramed for such products. Any
failure by Duramed to meet its obligations under this Agreement as a result of a general shortage
of raw materials (i.e., a shortage that not only affects Duramed, but also affects the general
market for such raw materials) shall not be considered a breach of this Agreement provided that
Duramed is meeting its obligations under Article IX. To the extent (other than as a result of a
Force Majeure Event) that Duramed fails to supply at least 80% of the quantities of Shire Product
in the aggregate ordered for a particular calendar quarter for two consecutive calendar quarters,
Shire may request and Duramed shall, at its cost and expense, qualify a second source of supply.
Such second source shall be qualified and ready to manufacture Shire Product within 12 months
following such Shire request. If Duramed fails to qualify and have ready such second source, then
Shire shall have the right to qualify and make ready such second source and Duramed shall promptly
reimburse Shire for costs and expenses incurred by it in so doing. Such second source shall be
used by Duramed to supply Shire Product to Shire under this Agreement at least to the extent
required to maintain the second source as a qualified manufacturer of Shire Product.

5

 

     Section 3.12. Product Specifications. Duramed shall manufacture all Shire Product
so that, at the time of delivery to Shire, the Shire Product conforms, in all material respects, to
the Product Specifications, cGMP and any reasonable requests communicated by Shire to Duramed in
order for Shire to comply with any legal or regulatory obligations applicable to Shire. At the
time of shipment of Shire Products, the Shire Products shall have a minimum remaining shelf life of
not less than that agreed upon by the Parties with respect to the Shire Product at issue as set
forth in Exhibit A. On mutual agreement of the Parties, the Parties may modify the Product
Specifications of the Shire Product by amendment to Exhibit A, unless such changes are required by
any regulatory authority, in which case Shire may unilaterally modify the Product Specifications of
the Shire Product. Upon modification of such Product Specifications, Duramed shall use
commercially reasonable efforts to alter its manufacturing processes to meet such Product
Specifications and shall not be liable for any failure to meet its obligations hereunder while
acting in good faith to meet the new Product Specifications.

     Section 3.13. Packaging Specifications. Duramed shall package the Shire Product in
accordance with the Packaging Specifications. Changes in the Packaging Specifications shall be
subject to the mutual agreement of the Parties on a schedule to be agreed by the Parties, taking
into account the time and cost required for Duramed to implement any necessary manufacturing or
packaging modifications. Shire shall compensate Duramed for the cost of any inventory of old
packaging that cannot be used as a result of any modification by Shire to the Packaging
Specifications, and for any other costs incurred as a result of the implementation of the
modifications to the Packaging Specifications requested by Shire. Shire will be responsible for
ensuring the accuracy of all information contained on all labels for Shire Products and for the
compliance of all such labels with applicable Laws and Regulatory Approvals.

     Section 3.14. Facility Maintenance; Inspection; Reports. Duramed shall, at all times,
maintain and operate all facilities where Shire Products are manufactured, packaged or tested, and
implement required quality control procedures to perform its obligations under this Agreement. Not
more than once every twelve (12) months (or more often in the case of a deficiency), Duramed shall
permit, or cause its contractors to permit, quality assurance representatives of Shire or
designated third parties and representatives of the applicable Government Authority to inspect such
facilities upon reasonable advance notice, during normal business hours and on a confidential
basis. Duramed shall promptly provide, or cause its contractor to provide, Shire with a copy of
any notice from the applicable Government Authority received at the conclusion of an inspection
relating to any Shire Product.

     Section 3.15. Subcontracting. Duramed shall have the right to subcontract manufacture
and supply under this Agreement to any Affiliate of Duramed or to a Third Party, provided
that, (i) Duramed shall procure that such Affiliates and Third Parties comply with the terms
and conditions of this Agreement, (ii) Duramed shall be liable for any non-performance or breach by
such Affiliate or Third Party, and (iii) any subcontracting to a Third Party shall be subject to
Shire’s approval, which approval shall not be unreasonably withheld.

     Section 3.16. Competing Products. Subject to the Product Development Agreement, Shire
recognizes and acknowledges that Duramed and its Affiliates have been, and

6

 

will continue to be, actively involved in the field in which the Shire Products may be sold.
Shire acknowledges that Duramed and its Affiliates currently, or may in the future, market, sell
and distribute products that compete directly with any Shire Product, and may continue to market,
sell and distribute these and other competing products throughout the Term of this Agreement.

ARTICLE IV

REPRESENTATIONS AND WARRANTIES

     Section 4.1. Mutual Representations. Each Party hereby represents and warrants to the
other Party, as of the date hereof, as follows:

     (a) Due Authorization. Such Party is a corporation duly incorporated and in good
standing (where such concept applies) as of the Effective Date, and the execution, delivery and
performance of this Agreement by such Party have been duly authorized by all necessary action on
the part of such Party.

     (b) Due Execution. This Agreement has been duly executed and delivered by such Party
and constitutes a legal, valid and binding obligation of such Party, enforceable against such Party
in accordance with its terms.

     (c) No Conflict. Such Party’s execution, delivery and performance of this Agreement
do not: (i) violate, conflict with or result in the breach of any provision of the charter or
by-laws (or similar organizational documents) of such Party; (ii) conflict with or violate any law,
rule, regulation or governmental order applicable to such Party or any of its assets, properties or
businesses; or (iii) conflict with, result in any breach of, constitute a default (or event which
with the giving of notice or lapse of time, or both, would become a default) under, require any
consent under, or give to others any rights of termination, amendment, acceleration, suspension,
revocation or cancellation of any agreement to which it is a party.

     (d) Duly Licensed. Such Party is duly licensed, authorized or qualified to do
business and is in good standing (where such concept applies) in every jurisdiction in which a
license, authorization or qualification is required for the ownership or leasing of its assets or
the transaction of business of the character transacted by it, except where the failure to be so
licensed, authorized or qualified would not have a material adverse effect on such Party’s ability
to fulfill its obligations hereunder.

ARTICLE V

QUALITY ASSURANCE

     Section 5.1. Duramed Compliance. Duramed shall manufacture, fill, package, handle and
warehouse the Shire Products in conformity with all applicable laws, cGMP requirements and the
Product Specifications. Shire shall maintain all Regulatory Approvals and all permits and
licenses issued by any Governmental Authority that are necessary to permit Duramed to manufacture
and supply the Shire Products. Duramed shall advise Shire of any information of which it becomes
aware arising out of Duramed’s activities hereunder that have adverse regulatory compliance and/or
reporting consequences affecting the Shire Products.

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     Section 5.2. Inspections. Duramed shall advise Shire of any requests by any
Governmental Authority for inspections of the premises used to manufacture Shire Products. In the
event the portion of Duramed’s facilities at which Shire Product are manufactured is inspected by
any Governmental Authority, Duramed shall use commercially reasonable efforts to ensure that Shire
shall have the right to be present during such inspection. To the extent relating directly to a
Shire Product, Duramed shall notify Shire of any alleged violations or deficiencies relating to a
facility at which any Shire Products are manufactured, packaged or stored, and, to the extent
relating directly to a Shire Product, shall disclose to Shire all relevant portions of any notice
of observations or potential violations as well as a copy of its response thereto.

     Section 5.3. Shire Compliance. Shire shall hold, store, handle, ship, deliver,
distribute and/or sell the Shire Products (i) in accordance with applicable cGMP requirements, laws
and Regulatory Approvals; and (ii) in compliance with the Product Specifications. Shire shall
enter into all necessary compliance agreements as may be reasonably required or designated by
Duramed, including but not limited to the quality agreement attached hereto as Exhibit C (the
“Quality Agreement”) and any other agreements to cover quality assurance and adverse
incident reporting, including the safety agreement attached hereto as Exhibit D (the “Safety
Agreement”).

     Section 5.4. Quality Control. Upon delivery of Shire Products to Shire, Shire shall
be solely responsible for compliance with all Laws and Regulatory Approvals with respect to the
Shire Products.

     Section 5.5. Rejection of Delivered Products. Within [*] of receipt of any Shire
Product, Shire shall inspect the Shire Product and advise Duramed of any defect whereby the Shire
Product does not conform to the Product Specifications. Any Shire Product not refused within [*]
shall be deemed accepted subject to Section 5.6 below; provided, however, that such
acceptance or deemed acceptance shall not adversely affect any claim for indemnification provided
in Article XI. If Shire desires to refuse acceptance, Shire shall, within such thirty (30) day
period, inform Duramed of its refusal to accept the defective Shire Product and the reason(s)
therefor. In the event that Shire refuses acceptance, Duramed, upon confirmation of the reasons
for refusal of the Shire Product, will replace the defective Shire Product or refund the purchase
price thereof, at Shire’s option. If Duramed and Shire do not agree on the refusal or rejection of
Shire Product, then any Party may refer the matter for final analysis to a specialized laboratory
of national reputation acceptable to both Parties for the purpose of determining the results. Any
determination by such laboratory shall be final and binding upon the Parties. The cost of any such
review by a laboratory shall be borne by Shire if it is determined that the Shire Product conforms
to the Product Specifications, and by Duramed if determined that it does not.

     Section 5.6. Latent Defects. Shire shall have the right to refuse and reject any
Collaboration Product within [*] from the date Shire becomes aware of a defect in a Shire Product
delivered hereunder, in the case of defects that are not evident upon a reasonable initial
inspection but which subsequently become evident.

     Section 5.7. Non-Conforming Products. Notwithstanding any other provisions of this
Agreement, Shire shall return to Duramed or its designee any Shire Products that do not conform
with the Product Specifications at the time of shipment to Shire, or if Shire and

8

 

Duramed mutually agree, to dispose of such Shire Products as Duramed may direct. Duramed shall
be responsible for the costs associated with the proper disposal of all such Shire Products not in
conformance with the Product Specifications at the time of shipment and shall promptly replace or
credit, at the option of Duramed, such non-conforming Shire Products.

     Section 5.8. Cost of Recall. In the event that any Shire Product is quarantined or
recalled, or is subject to a stop-sale action, whether voluntary or by the action of any
Governmental Authority, or as a result of the revocation or expiration of any Regulatory Approval,
any expenses, including any out-of-pocket administrative costs and reasonable fees of any experts
or attorneys that may be utilized by either Party, government fines or penalties, related to such
recall, quarantine or stop-sale, shall be borne by Shire unless it is determined that the reason
for the quarantine, recall or stop-sale action is the result of the breach by Duramed of its
obligations under this Agreement, and in such case such expenses shall be shared according to the
relative responsibility of each Party. Such determination may be made by the Governmental
Authority involved, or by mutual agreement of the Parties following examination and review of all
records pertinent to the manufacture of the Shire Product subject to such recall.

     Section 5.9. Regulatory Actions. If any regulatory authority in the Shire Territory
takes any action with respect to a Shire Product that requires a response or action by Duramed,
Duramed shall use commercially reasonable efforts, at the expense of Shire, to carry out the
response or action, at all times in consultation with Shire, and promptly thereafter Duramed shall
meet with Shire and agree a suitable plan of action in order to try and rectify and/or address any
problem(s) identified by the Regulatory Authority within a reasonable period of time at the expense
of Shire. Notwithstanding the foregoing, if any of the above expenses result from Duramed’s
breach, negligence or willful misconduct hereunder, then any expenses incurred under this Section
5.9 shall be Duramed’s responsibility.

ARTICLE VI

PRICE AND PAYMENTS

     Section 6.1. Clinical Non-Seasonique Supply Prices. [*]

[*]

     Section 6.2. Commercial Non-Seasonique Supply Prices. [*]

[*]

     Section 6.3. Clinical Seasonique Prices. [*]

[*]

     Section 6.4. Commercial Seasonique Supply Prices. [*]

[*]

     Section 6.5. Unit Price Negotiation. [*].

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     Section 6.6. Records. Duramed shall keep complete and accurate records, consistent
with GAAP, of the Fully Allocated Manufacturing Costs and API Costs.

     Section 6.7. Invoices. Duramed may invoice for Shire Product at any time following
tender thereof to Shire’s carrier. All invoices shall be sent to a single address specified in
writing by Shire. Payment for Shire Product shall be due within [*] after the date of the invoice
by check or electronic funds transmission in United States dollars without any offset or deduction
of any nature whatsoever. All electronic payments shall be made to such account as Duramed shall
have specified in writing to Shire with written confirmation of payment sent by facsimile to such
address as Duramed shall have specified in writing to Shire. If Shire fails to pay any undisputed
invoiced amount when due, a service charge will be imposed by Duramed equal to the [*] per month or
the highest rate permitted by law of the outstanding amount for each month or portion thereof that
such amount is overdue.

     Section 6.8. Taxes. The purchase price of Shire Products as determined in accordance
with Section 6.1 shall be exclusive of any applicable value added tax and any other taxes, duties
and impositions that, if applicable, shall be paid by Shire to Duramed at the same time as the
purchase price for such Shire Product. Shire shall bear the cost of any such taxes, duties or
impositions of any kind, nature or description applicable to the sale and transportation of Shire
Product, and Shire will forthwith pay to Duramed all such amounts upon demand.

     Section 6.9. Separate Sale. Each shipment of Shire Product shall constitute a
separate sale, obligating Shire to pay therefor, whether such shipment is in whole or only partial
fulfillment of any Purchase Order.

     Section 6.10. Deductions. Shire shall not to make any deductions of any kind from any
payments due to Duramed hereunder unless Shire will have received prior written authorization from
Duramed authorizing such deduction.

     Section 6.11. Audit.

     (a) Audit. Shire shall have the right to have an independent certified public
accounting firm of internationally recognized standing, reasonably acceptable to Duramed, to have
access during normal business hours, and upon reasonable prior written notice, to such of the
records of Duramed as may be reasonably necessary to verify the accuracy of amounts paid by Shire
under this Agreement for any calendar year ending not more than three (3) years prior to the date
of such request; provided, however, that, Shire shall not have the right to conduct more than one
such audit in any twelve (12) month period and that Shire shall not be permitted to audit the same
period of time more than once. The accounting firm shall disclose to Shire only whether the
various expenses subject to reimbursement under this Agreement are correct or incorrect and the
specific details concerning any discrepancies. Shire shall bear all costs of such audit, unless
the audit reveals a discrepancy in Shire’s favor of more than five percent (5%), in which case
Duramed shall bear the cost of the audit. If Duramed disputes the findings pursuant to this
Section 6.11, the Parties shall meet and discuss such dispute.

     (b) Payment of Additional Amounts. If, based on the results of any audit, (a)
additional payments are owed by Shire to Duramed under this Agreement, then Shire shall make

10

 

such additional payments, or (b) the payments previously made by Shire to Duramed under this
Agreement are in excess of the amounts that were actually required to be made, then Duramed shall
return such excess payments, in each case within fifteen (15) Business Days after the accounting
firm’s written report is delivered to the Parties.

ARTICLE VII

TERM AND TERMINATION

     Section 7.1. Term. The term of this Agreement shall commence on the Effective Date
and shall continue until terminated in accordance with this Article VII (the “Term”).
Shire may terminate this Agreement as to the supply of particular Shire Product at any time on one
(1) years written notice to Duramed. Subject to Article VIII, Duramed may terminate this Agreement
as to the supply of particular Shire Product at any time on eighteen (18) months written notice to
Shire, provided that Duramed may not terminate this Agreement under this sentence until ten (10)
years following the Effective Date. Termination of this Agreement with respect to one or more
Shire Products shall not relieve the Parties of any obligations with respect to any other Shire
Products, and this Agreement shall remain in effect as to such other Shire Products.

     Section 7.2. Termination of Exclusivity. Notwithstanding the provisions of Section
7.1, the obligations of the Parties under Section 2.1 shall be effective as of the date of
execution of this Agreement and may not be terminated except on mutual agreement of the Parties.
Termination of this Agreement as to the supply of any particular Shire Product under Section 7.1
shall not affect the rights and obligations of the Parties with respect to the other Shire Products
under Section 2.1.

     Section 7.3. Termination for Cause. Either Party may terminate this Agreement as to
the supply of a particular Shire Product at any time in the event that the other Party materially
breaches this Agreement as to such Shire Product and such material breach continues uncured for a
period of ninety (90) days after written notice thereof; provided, however, in the
event that the breaching Party has in good faith commenced cure within such ninety (90) day period,
but cannot practically complete such cure within such ninety (90) day period, the breaching Party
shall have an additional ninety (90) day cure period. In the event a material breach of this
Agreement is incapable of cure or cannot be cured in the time periods set forth in the previous
sentence acting using commercially reasonable efforts, without limiting any other rights of the
non-breaching Party, including the right to seek injunctive relief, the non-breaching Party shall
not have the right to terminate this Agreement if (i) the breaching Party is providing full
cooperation to resolve and/or mitigate the breach, and (ii) the breach was not caused by willful
misconduct by the breaching Party.

     Section 7.4. Survival. The provisions of Sections 5.8 and 7.4, and Articles VIII, X,
XI and XII shall survive termination or expiration of this Agreement. Termination of this
Agreement shall not affect the obligation of any Party to pay the other Party any amounts due
hereunder accrued prior to the termination date hereof. Except in the event of termination by
Duramed under Section 7.3, upon termination of this Agreement Duramed shall deliver to Shire on an
ex-works basis all manufactured and work-in progress quantities of Shire Product in its possession
that have been manufactured in respect of a specific Purchase Order(s) accepted by

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Duramed hereunder subject to payment in advance therefor by Shire. The right to terminate
this Agreement shall not prejudice any other right or remedy in equity or at law of a Party in
respect of any breaches of this Agreement.

ARTICLE VIII

TERMINATION ASSISTANCE SERVICES

     Section 8.1. Termination Assistance Services. If (i) Duramed terminates this
Agreement as to the supply of particular Shire Product under Section 7.1 (and Shire intends to
continue Commercializing the applicable Shire Product), or (ii) Shire terminates this Agreement
under Section 7.3 (and Shire intends to continue Commercializing the applicable Shire Product),
Duramed shall for a period of one (1) year thereafter, upon Shire’s request, provide any
cooperation reasonably requested by Shire that may be required to facilitate the transfer of the
manufacture of the applicable Shire Product to Shire or Shire’s designee (“Termination
Assistance Services”). Shire shall reimburse Duramed for the reasonable costs of Duramed in
providing Termination Assistance Services. The rights of Shire under this Section 8.1 shall be
without prejudice to the Parties’ rights to pursue legal remedies for breach of this Agreement,
either for breaches prior to termination or during the period this Agreement is continued in force
post termination.

     Section 8.2. Development of Changeover Plan. If and to the extent requested by Shire,
whether prior to, upon, or following termination of this Agreement by Shire, Duramed shall use
commercially reasonable efforts to assist Shire in developing a plan that shall specify the tasks
to be performed by the Parties in connection with the Termination Assistance Services and the
schedule for the performance of such tasks (a “Changeover Plan”). The Changeover Plan
shall include descriptions of the services, fees, documentation and access requirements that will
promote an orderly transition of the manufacture of Shire Product to Shire or its designee.

     Section 8.3. Know-How, Infrastructure, and Software. In connection with the
Termination Assistance Services, Duramed shall make available to Shire or its designee, to the
extent owned or controlled by and in the possession of Duramed and reasonably required to
manufacture the applicable Shire Product, (i) copies of all applicable requirements, standards,
policies, reports and report formats, user manuals, technical manuals, system architecture,
processes, operating procedures and other documentation, (ii) copies of flow charts of the
manufacturing procedures and work instructions related to manufacturing the relevant Shire Product,
(iii) a list of all material equipment, including the source of such equipment, utilized in the
production of the applicable Shire Product, (iv) copies of all current specifications, including
packaging, for the relevant Shire Product, (v) copies of all standard operating procedures for the
manufacturing procedures to be made available to Shire, (vi) all necessary environmental conditions
necessary to manufacture the relevant Shire Product and copies of any existing external
environmental impact studies based on the materials or methods employed in the manufacturing method
to be made available to Shire, and (vii) such other documentation as the Parties may agree.

ARTICLE IX

FORCE MAJEURE

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     Section 9.1. Force Majeure. No Party shall be responsible for failure or delay in
performance hereunder due to reasons beyond its reasonable control, including without limitation,
by reason of fire, flood, riot, freight embargoes, acts of God or of the public enemy, war or civil
disturbances, general shortage of raw materials (i.e., a shortage that not only affects Duramed,
but also affects the general market for such raw materials), or any future laws, rules, regulations
or acts of any government affecting a Party that would delay or prohibit performance hereunder (a
“Force Majeure Event”). Upon the occurrence of a Force Majeure Event, the Party whose
performance is so affected shall promptly give notice to the other Party of the occurrence or
circumstance upon which it intends to rely to excuse its performance. During the duration of the
Force Majeure Event, the Party so affected shall use its reasonable commercial efforts to avoid or
remove such Force Majeure Event and shall take reasonable steps to resume its performance under
this Agreement with the least possible delay. Any Force Majeure Event must be beyond the control
and without the fault or negligence of the Party claiming excusable delay, provided that, breaches
by any Party’s subcontractors shall not excuse any delay or failure by that Party.

ARTICLE X

CONFIDENTIALITY

     Section 10.1. Confidential Information. As used in this Agreement, the term
“Confidential Information” means all secret, confidential or proprietary information or
data, whether provided in written, oral, graphic, video, computer, electronic or other form,
provided pursuant to this Agreement or generated pursuant to this Agreement by one Party or its
Affiliates (the “Disclosing Party”) to the other Party or its Affiliates (the
“Receiving Party”), including but not limited to, information relating to the Disclosing
Party’s existing or proposed research, development efforts, patent applications, business or
products, and any other materials that have not been made available by the Disclosing Party to the
general public. Confidential Information shall not include any information or materials that:

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

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

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

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

(e) were independently discovered or developed by or on behalf of the Receiving
Party without the use of the Confidential Information belonging to the

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other Party, to the extent such Receiving Party has documentary evidence to that
effect.

     Section 10.2. Confidentiality Obligations. Each of Duramed and Shire shall keep
confidential all Confidential Information of the other Party with the same degree of care it
maintains the confidentiality of its own Confidential Information but in no event less than a
reasonable degree of care. Neither Party shall use such Confidential Information for any purpose
other than in performance of this Agreement or disclose the same to any other Person other than to
such of its and its Affiliates’ directors, managers, employees, independent contractors, agents or
consultants who are bound by confidentiality obligations consistent with those contained herein and
who have a need to know such Confidential Information to implement the terms of this Agreement or
enforce its rights under this Agreement. Upon termination of this Agreement, the Receiving Party
shall return or destroy all documents, tapes or other media containing Confidential Information of
the Disclosing Party that remain in the possession of the Receiving Party and its Affiliates or
their directors, managers, employees, independent contractors, agents or consultants, except that
the Receiving Party may keep one copy of the Confidential Information in the legal department files
of the Receiving Party, solely for archival purposes. Such archival copy shall continue to be
subject to the provisions of this Article X.

     Section 10.3. Permitted Disclosure and Use. Notwithstanding Section 10.2, a Party may
disclose Confidential Information belonging to the other Party only to the extent such disclosure
is reasonably necessary to: (a) obtain Regulatory Approval to the extent such disclosure is made to
a Governmental Authority; (b) comply with or enforce any of the provisions of this Agreement; (c)
comply with Laws; or (d) comply with applicable stock exchange regulations. If a Party deems it
necessary to disclose Confidential Information of the other Party pursuant to this Section 10.3,
such Party shall give reasonable advance notice of such disclosure to the other Party to permit
such other Party sufficient opportunity to object to such disclosure or to take measures to ensure
confidential treatment of such information. In addition, notwithstanding Section 10.2, the Parties
shall cooperate to prepare standardized public responses to anticipated inquiries from the public,
press, stockholders, investors and/or analysts with respect to the activities hereunder. Despite
the foregoing, each Party agrees that the other Party is free to disclose this Agreement in its
entirety to the United States Federal Trade Commission and the United States Department of Justice,
or to any court with jurisdiction over the litigations settled under the Settlement Agreement
between Shire Laboratories Inc. and Barr Laboratories Inc. dated August 14, 2006.

     Section 10.4. Unauthorized Disclosure. The Receiving Party acknowledges and agrees
that the Confidential Information of the Disclosing Party constitutes proprietary information and
trade secrets valuable to the Disclosing Party, and that the unauthorized use, loss or outside
disclosure of such Confidential Information shall be presumed to cause irreparable injury to the
Disclosing Party.

     Section 10.5. Notification. The Receiving Party shall notify the Disclosing Party
promptly upon discovery of any unauthorized use or disclosure of the Disclosing Party’s
Confidential Information, and shall cooperate with the Disclosing Party in any reasonably requested
fashion to assist the Disclosing Party to regain possession of such Confidential Information and to
prevent its further unauthorized use or disclosure. The Receiving Party

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acknowledges that monetary damages may not be a sufficient remedy for unauthorized disclosure
of Confidential Information and that the Disclosing Party may be entitled, without waiving other
rights or remedies, to such injunctive or equitable relief as may be deemed proper by a court of
competent jurisdiction in the event of such unauthorized disclosure.

     11.5 Confidentiality of this Agreement. The terms of this Agreement shall be
Confidential Information of each Party and, as such, shall be subject to the provisions of this
Article X.

ARTICLE XI

INDEMNIFICATION

     Section 11.1. Indemnification by Shire. Shire hereby agrees to hold Duramed, its
Affiliates, and their respective directors, agents and employees harmless from and against any and
all Losses arising in connection with any and all charges, complaints, actions, suits, proceedings,
hearings, investigations, claims, demands, judgments, orders, decrees, stipulations or injunctions
by a third party (each a “Third Party Claim”) resulting directly from (a) any breach by
Shire of any of its representations, warranties, covenants or obligations pursuant to this
Agreement, (b) the negligence or willful misconduct by Shire or its Affiliates or their respective
officers, directors, employees, agents or consultants in performing any obligations under this
Agreement, (c) the Shire Product, including the use, handling, storage, sale or other disposition
of Shire Product (including, without limitation, those Third Party Claims that involve product
defect, product liability, death or bodily injury (or allegations thereof) to any individual or any
property, or (d) infringement of intellectual property based on the Product Specification,
Packaging Specifications, manufacture, use, sale, offer for sale, importation or other distribution
of Shire Product, except to the extent that such Losses in (a) through (c) result from the
negligence or willful misconduct of Duramed, or the breach of this Agreement by Duramed.

     Section 11.2. Indemnification by Duramed. Duramed hereby agrees to hold Shire, its
Affiliates, and their respective directors, agents and employees harmless from and against any and
all Losses arising in connection with any and all Third Party Claims resulting directly from (a)
any breach by Duramed of any of its representations, warranties, covenants or obligations pursuant
to this Agreement, or (b) the negligence or willful misconduct of Duramed or its Affiliates or
their respective officers, directors, employees, agents or consultants in performing any
obligations under this Agreement, or (c) claims that involve product defect, product liability,
death or bodily injury (or allegations thereof) to any individual or any property to the extent
that such claim results from Duramed’s breach, negligence or willful misconduct hereunder,, except
to the extent that such Losses in (a) through (c) result from the negligence or willful misconduct
of Shire, or the breach of this Agreement by Shire.

     Section 11.3. Notice of Claim. All indemnification claims in respect of any
indemnitee seeking indemnity hereunder (collectively, the “Indemnitees” and each an
“Indemnitee”) shall be made solely by the corresponding Party (the “Indemnified
Party”). The Indemnified Party shall give the indemnifying Party (the “Indemnifying
Party”) prompt written notice (an “Indemnification Claim Notice”) of any Losses or the
discovery of any fact upon which such Indemnified Party intends to base a request for
indemnification hereunder, but in no event shall the Indemnifying Party be liable for any Losses
that result from any delay in providing such notice which materially prejudices the defense of such
Third Party Claim. Each

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Indemnification Claim Notice must contain a description of the claim and the nature and amount
of such Loss (to the extent that the nature and amount of such Loss are known at such time).
Together with the Indemnification Claim Notice, the Indemnified Party shall furnish promptly to the
Indemnifying Party copies of all notices and documents (including court papers) received by any
Indemnitee in connection with the Third Party Claim. The Indemnifying Party shall not be obligated
to indemnify the Indemnified Party to the extent any admission or statement made by the Indemnified
Party materially prejudices the defense of such Third Party Claim.

     Section 11.4. Control of Defense. At its option, the Indemnifying Party may assume
the defense of any Third Party Claim subject to indemnification hereunder by giving written notice
to the Indemnified Party within thirty (30) days after the Indemnifying Party’s receipt of an
Indemnification Claim Notice. Upon assuming the defense of a Third Party Claim, the Indemnifying
Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel it
selects. Should the Indemnifying Party assume the defense of a Third Party Claim, the Indemnifying
Party shall not be liable to the Indemnified Party or any other Indemnitee for any legal expenses
subsequently incurred by such Indemnified Party or other Indemnitee in connection with the
analysis, defense or settlement of the Third Party Claim.

     Section 11.5. Right to Participate in Defense. Without limiting Section 11.4, any
Indemnitee shall be entitled to participate in, but not control, the defense of a Third Party Claim
for which it has sought indemnification hereunder and to employ counsel of its choice for such
purpose; provided, however, that such employment shall be at the Indemnitee’s own expense unless
(a) the employment thereof has been specifically authorized by the Indemnifying Party in writing,
or (b) the Indemnifying Party has failed to assume the defense and employ counsel in accordance
with Section 11.4 (in which case the Indemnified Party shall control the defense).

     Section 11.6. Settlement. With respect to any Losses relating solely to the payment
of money damages in connection with a Third Party Claim and that shall not result in the
Indemnitee’s becoming subject to injunctive or other relief or otherwise adversely affect the
business of the Indemnitee in any manner, and as to which the Indemnifying Party shall have
acknowledged in writing the obligation to indemnify the Indemnitee hereunder, the Indemnifying
Party shall have the sole right to consent to the entry of any judgment, enter into any settlement
or otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its reasonable
discretion, shall deem appropriate (provided, however that such terms shall include a complete and
unconditional release of the Indemnified Party from all liability with respect thereto), and shall
transfer to the Indemnified Party all amounts which said Indemnified Party shall be liable to pay
prior to the time of the entry of judgment. With respect to all other Losses in connection with
Third Party Claims, where the Indemnifying Party has assumed the defense of the Third Party Claim
in accordance with Section 11.4, the Indemnifying Party shall have authority to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of such Loss provided it
obtains the prior written consent of the Indemnified Party (which consent shall be at the
Indemnified Party’s reasonable discretion). The Indemnifying Party that has assumed the defense of
the Third Party Claim in accordance with Section 11.4 shall not be liable for any settlement or
other disposition of a Loss by an Indemnitee that is reached without the written consent of such
Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, no Indemnitee shall admit any liability with respect to, or settle,
compromise or discharge, any Third Party Claim without first offering to the

16

 

Indemnifying Party the opportunity to assume the defense of the Third Party Claim in
accordance with Section 11.4.

     Section 11.7. Cooperation. If the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, the Indemnified Party shall, and shall cause each other Indemnitee to,
cooperate in the defense or prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings,
trials and appeals as may be reasonably requested in connection with such Third Party Claim. Such
cooperation shall include access during normal business hours afforded to the Indemnifying Party
to, and reasonable retention by the Indemnified Party of, records and information that are
reasonably relevant to such Third Party Claim, and making Indemnitees and other employees and
agents available on a mutually convenient basis to provide additional information and explanation
of any material provided hereunder, and the Indemnifying Party shall reimburse the Indemnified
Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation.

     Section 11.8. Expenses of the Indemnified Party. Except as provided above, the
reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred
by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a calendar
quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and subject to refund in the event the
Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

     Section 11.9. Insurance. At all times from the Effective Date until three (3) years
following termination or expiration of this Agreement, each of Shire and Duramed will maintain
product liability insurance (or self insurance), that is reasonable and customary in the U.S.
pharmaceutical industry for companies of comparable size, but in no event less than $10,000,000 per
occurrence and $10,000,000 in the aggregate limit of liability per year. Each of Shire and Duramed
shall provide written proof of such insurance or self insurance to the other Party upon request.

     11.10. Exclusion of Certain Damages. IN NO EVENT SHALL ANY PARTY BE LIABLE TO ANY
OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OF ANY KIND
ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, OR FOR ANY DIRECT OR INDIRECT LOSS OF PROFIT,
LOST BUSINESS OPPORTUNITY, LOSS OF OR DISRUPTION TO PRODUCTION OR GOODWILL, EXCEPT TO THE EXTENT
SUCH DAMAGES: (A) ARE INCLUDED IN A THIRD-PARTY CLAIM FOR WHICH SUCH PARTY IS INDEMNIFIED
HEREUNDER; OR (B) ARE FOR BREACH OF CONFIDENTIALITY OBLIGATIONS.

ARTICLE XII

MISCELLANEOUS

     Section 12.1. Entire Agreement; Amendment. This Agreement, together with the Product
Development Agreement, including the exhibits attached hereto and thereto (each of

17

 

which is hereby and thereby incorporated herein and therein by reference), set forth the
complete, final and exclusive agreement and all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties hereto and supersedes and
terminates all prior agreements and understandings between the Parties, which shall continue to
govern the obligations of the Parties with respect to information disclosed thereunder with respect
to periods prior to the Effective Date. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between the Parties other
than as are set forth herein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized
officer of each Party. For the avoidance of doubt, the Parties agree that all covenants, promises,
agreements, warranties, representations, conditions, and understandings set forth herein are made
and deemed effective as of the Effective Date, and that the execution of this Agreement shall not
constitute a waiver of any right or claim of either Party as of the Effective Date.

          Section 12.2. Notices. All notices or other communications that are required or
permitted under this Agreement shall be in writing and delivered personally, sent by facsimile (and
promptly confirmed by personal delivery or overnight courier as provided in this Agreement), or
sent by internationally-recognized overnight courier to the addresses below. Any such
communication shall be deemed to have been given (a) when delivered, if personally delivered or
sent by facsimile on a Business Day (so long as promptly confirmed by personal delivery or
overnight courier as provided in this Agreement), and (b) on the second Business Day after
dispatch, if sent by internationally-recognized overnight courier. Unless otherwise specified in
writing, the mailing addresses of the Parties shall be as described below.

	 	 	 
	For Duramed:

	 	Duramed Laboratories, Inc.
	 

	 	400 Chestnut Ridge Road
	 

	 	Woodcliff Lake, NJ 07677
	 

	 	Phone: 201-930-3300
	 

	 	Fax: 201-930-3330
	 

	 	Attention: President
	 
	 	 
	with a copy to:

	 	Barr Pharmaceuticals, Inc.
	 

	 	400 Chestnut Ridge Road
	 

	 	Woodcliff Lake, NJ 07677
	 

	 	Phone: 201-930-3300
	 

	 	Fax: 888-843-0563
	 

	 	Attention: General Counsel
	 
	 	 
	For Shire:

	 	Shire LLC
	 

	 	725 Chesterbrook Boulevard
	 

	 	Wayne, Pennsylvania 19087-5637
	 

	 	Fax: (484) 595-8163
	 

	 	Attention: General Counsel
	 
	 	 
	with a copy to:

	 	Morgan, Lewis & Bockius LLP
	 

	 	502 Carnegie Center

18

 

	 	 	 
	 

	 	Princeton, NJ 08540
	 

	 	Fax: (609) 919-6701
	 

	 	Attention: Randall B. Sunberg

          Section 12.3. Independent Contractors. In making and performing this Agreement, Shire
and Duramed shall act at all times as independent contractors and nothing contained in this
Agreement shall be construed or implied for any purpose to create an agency, partnership, limited
partnership, joint venture or employer and employee relationship between Shire and Duramed and this
Agreement shall not be construed to suggest otherwise. At no time shall one Party make commitments
or incur any charges or expenses for or in the name of the other Party. Except as otherwise
provided in this Agreement, each Party shall be solely responsible for its own costs and expenses
associated with this Agreement.

          Section 12.4. Maintenance of Records. Each Party shall keep and maintain all records
required by Law with respect to the Shire Products and shall make copies of such records available
to the other Party upon reasonable request.

          Section 12.5. United States Dollars. References in this Agreement to “Dollars” or “$”
shall mean the legal tender of the United States.

          Section 12.6. No Strict Construction. This Agreement has been prepared jointly and
shall not be strictly construed against either Party.

          Section 12.7. Assignment. Neither Party shall sell, transfer, assign, delegate,
pledge or otherwise dispose of, whether voluntarily, involuntarily, by operation of Law or
otherwise, this Agreement or any of its rights or obligations under this Agreement without the
prior written consent of the other Party (which consent may be granted, withheld or conditioned at
such other Party’s sole and absolute discretion); provided, however, that either Party may assign
or transfer this Agreement or any of its rights or obligations under this Agreement without the
consent of the other Party to any Affiliate of such Party, or to any Third Party (a) with which it
merges or consolidates, or to which it transfers all or substantially all of its assets to which
this Agreement pertains or (b) in part, in connection with the sale or transfer of such Party’s
business relating to Commercialization of a Collaboration Product within a particular country. The
assigning Party (unless it is not the surviving entity) shall remain jointly and severally liable
with, and shall guarantee the performance of, the relevant Affiliate or Third Party assignee under
this Agreement, and the relevant Affiliate assignee, Third Party assignee or surviving entity shall
assume in writing all of the assigning Party’s obligations under this Agreement. Any purported
assignment or transfer in violation of this Section 12.7 shall be void ab initio and of no force or
effect. Notwithstanding anything to the contrary herein or in the Product Development Agreement,
in the event any assignment by Shire hereunder gives rise to any obligation to withhold any amounts
payable to Duramed, Shire, or its assignee, shall be entitled to deduct from all payments due under
this Agreement the amount of all applicable withholding taxes to the extent Shire, or its assignee,
pays such taxes to the appropriate governmental authority on behalf of Duramed. Shire shall
properly furnish Duramed with copies of tax receipts evidencing the payment of all such taxes,
levies and assessments. Duramed and Shire shall cooperate with each other in obtaining any
exemption from, a refund for, or reduced rate of tax available under any applicable law or tax
treaty. Notwithstanding the foregoing, Shire shall be liable for, and

19

 

indemnify Duramed against, any non-U.S. taxes, any value-added or sales taxes, any duties or
levies and assessments, howsoever designated or computed that are required to be paid or withheld
by Shire on such payments. Shire shall so indemnify Duramed within forty-five (45) days of Shire’s
receipt of notification from Duramed (in accordance with Section 12.2 hereof) that either (i) based
upon current facts and circumstances, Duramed does not have or will not have during the applicable
tax year any or sufficient foreign tax credits available to utilize to offset such tax liability;
or (ii) Duramed has applied for a refund from the taxing authority at issue (such notice to include
a copy of such refund application). Notwithstanding anything in this Agreement to the contrary, in
the event that withholding taxes are paid on behalf of Duramed by Shire, if Duramed uses a foreign
tax credit received as a result of the payment of withholding taxes by Shire and thereby reduces
the amount of U.S. income tax that Duramed otherwise would have paid, or otherwise receives a
refund, Duramed shall refund to Shire the amount of such reduction with respect to such foreign tax
credit or such refund.

          Section 12.8. Counterparts. This Agreement may be executed in two counterparts, each
of which shall be deemed an original, but all of which together shall constitute one and the same
instrument. Signatures provided by facsimile transmission shall be deemed to be original
signatures.

          Section 12.9. Further Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be reasonably necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

          Section 12.10. Severability. If any one or more of the provisions of this Agreement
is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal
can be or is taken, the provision shall be considered severed from this Agreement and shall not
serve to invalidate any remaining provisions hereof. The Parties shall make a good fait effort to
replace any invalid or unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement may be realized.

          Section 12.11. Headings. The headings for each article and section in this Agreement
have been inserted for convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular article or section.

          Section 12.12. No Waiver. Any delay in enforcing a Party’s rights under this
Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of
such Party’s rights to the future enforcement of its rights under this Agreement, excepting only as
to an express written and signed waiver as to a particular matter for a particular period of time.

[signature page follows]

20

 

     IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be signed by their
respective representatives thereunto duly authorized, all as of the date first written above.

	 	 	 	 	 
	SHIRE LLC  
	 
	 	 	 	 
	By:
	 	/s/ Matthew Emmens	 	 
	 
	 	 	 	 
	Name:
	 	Matthew Emmens	 	 
	Title:

	 	CEO
	 	 
	 
	 	 	 	 
	DURAMED PHARMACEUTICALS, INC.
	 
	 	 	 	 
	By:
	 	/s/ Fred Wilkinson	 	 
	 
	 	 	 	 
	Name:

	 	Fred Wilkinson
	 	 
	Title:

	 	President & C.O.O.

	 	 

SHIRE plc, a British public limited company having a principal place of business at Hampshire
International Business Park, Chineham, Basingstoke, England RG24 8EP, hereby guarantees in the
performance of Shire of all obligations of Shire under this Agreement, in accordance with the terms
and conditions of this Agreement, including any applicable notice or cure periods.

	 	 	 
	SHIRE PLC
	 
	 	 
	By:
	 	/s/ Matthew Emmens
	 
	 	 
	Name:
	 	Matthew Emmens
	Title:
	 	CEO

[Signature Page to Shire Products Supply Agreement]

 

 

EXHIBIT A

PRODUCT SPECIFICATIONS

All Shire Product supplied hereunder shall have a remaining expiry period of:

	(a)	 	Not less than [*] months, if the shelf life is [*] months;
	 
	(b)	 	Not less than [*] months, if the shelf life is [*] months; and
	 
	(c)	 	Not less than [*] months, if the shelf life is [*] months.

 

 

EXHIBIT B

PACKAGING SPECIFICATIONS

 

 

EXHIBIT C

STEERING COMMITTEE CHARTER

	A.	 	Purpose and Functions of the Steering Committee.
	 
	 	 	The Steering Committee will (i) enable, coordinate and guide the activities of the Parties
relating to the development of Collaboration Products, (ii) define and implement, on an
ongoing basis, a technology roadmap, and (iii) implement the Agreement and, without limiting
the rights of the Parties under ARTICLE 16, resolve any disputes or disagreements related to
the implementation thereof.
	 
	B.	 	Development Plans. Upon delivery of each Development Plan to the Steering Committee,
each Party shall review the Development Plan and provide written comments and suggestions to
the Steering Committee within [*] after receipt. The Steering Committee may incorporate any
such revisions that it deems appropriate and will provide a recommendation of the Development
Plan to each of the Parties. Notwithstanding the foregoing, Shire shall make all final
decisions with respect to Development Plans affecting the Shire Territory and Duramed shall
make all final decisions with respect to Development Plans in the Duramed Territory.
	 
	C.	 	Reporting. The Steering Committee shall report to the Parties from time to time, but
in no event less often than once each quarter. Such report shall describe all projects
undertaken in performance of each Development Plan. Such report also shall include any other
information reasonably requested by the Parties.
	 
	D.	 	Steering Committee Responsibilities. The Steering Committee shall have the duty
and authority to perform the functions described above and the following additional functions:

	 	(a)	 	General oversight of the activities of the Parties under this
Agreement, including the progress of work under each Development Plan.
	 
	 	(b)	 	Review of quarterly reports before such reports are sent to the
Parties regarding the progress of the Parties’ efforts under each Development
Plan.
	 
	 	(c)	 	Review of the technology budget and quarterly spending in
connection with each Development Plan.

	E.	 	Membership and Procedure.

	 	1.	 	Membership on the Committee.

	 	(a)	 	Members. The Steering Committee members (each a
“Member”) will include the Collaboration Managers, [*].

 

 

	 	(b)	 	Qualifications. The qualifications of any Member shall
be determined in the discretion of the Party that appoints such Member.
	 
	 	(c)	 	Removal and Vacancies. Each Party may, in its sole
discretion, remove any Member appointed by it to the Steering Committee. If
any Member is removed or resigns from the Steering Committee or otherwise
ceases to serve on the Steering Committee for any reason (e.g., by reason of
the separation of such Member from employment by the Party that appointed such
Member, such Member’s death or disability, etc.), the Party that appointed such
Member shall promptly notify the other Party of such Member’s withdrawal from
the Steering Committee. On notice to the other Party, any vacancy on the
Steering Committee shall be filled by the Party that appointed the Member who
resigned from, was removed from, or for any other reason ceased to serve on the
Steering Committee .

     2. Additional Attendees at Steering Committee Meetings. The Steering Committee may
establish rules with respect to the attendance at the Steering Committee meetings of staff and
other invitees. All such rules shall be consistently applied to both Parties.

     3. Voting. Each Member shall be entitled to one (1) vote to be cast by such Member.
No vote may be cast by proxy. Except as expressly provided below, all actions, determinations or
resolutions of the Steering Committee at a meeting shall require the affirmative vote of the
Members present at such meeting at which a quorum (meaning more than half of the total number of
Members) is present; provided that [*] may be [*], and the [*] not be [*] action, decision,
determination or resolution.

     4. Notice; Waiver; Meeting Location. The Steering Committee shall meet at least [*].
Such meetings shall be held upon not less than [*] written notice. Additional meetings of the
Steering Committee shall be held (A) at such other times as may be determined by the Steering
Committee, or (B) at the request of the Collaboration Manager of either Party upon not less than
[*] written notice. The Duramed Collaboration Manager shall determine the location of each meeting
of the Steering Committee taking into account any travel considerations by Members of the Steering
Committee. Notice may be provided in writing, via facsimile, or email to each Member. The
presence of any Member at a meeting shall constitute a waiver of notice of the meeting with respect
to such Member, unless such Member declares at the meeting that such Member objects to the notice
as having been improperly given. The Steering Committee shall cause written minutes to be prepared
of all actions taken by the Steering Committee and shall cause a copy thereof to be delivered to
each Member within [*]. No action may be taken by the Steering Committee without a meeting to
consider the matter unless each Party issues a written waiver of such meeting and unless a consent
or consents in writing, setting forth the action so taken, are signed by the Members of the
Steering Committee having not less than the minimum number of votes that would be necessary to
authorize or take such action at a meeting at which all the Members of the Steering Committee were
present and voted.

     5. Meetings by Telecommunications. Members of the Steering Committee shall have the
right to participate in all meetings of the Steering Committee in person, by means of a conference
telephone, or by videoconference or similar telecommunications service by means of

 

 

which all persons participating in the meeting can hear each other at the same time and
participation by such means shall constitute presence in person at a meeting. Any reference in
this Exhibit to attendance or participation by a Member at a meeting of the Steering Committee
shall be deemed to refer to attendance in person or attendance by means of a telecommunications
service pursuant to this paragraph.

     6. Compensation of Members of the Steering Committee. The Members of the Steering
Committee, in their capacity as such, shall not receive compensation, except with respect to any
Member as such Member and the Party that appointed such Member shall otherwise mutually agree.
Each Party shall bear the cost and expenses incurred by its appointed Members of the Steering
Committee in connection with the activities of the Steering Committee.

     7. Conflicts. In the event of any conflict between the provisions of this Exhibit and
the provisions of the Collaboration Agreement, the provisions of the Collaboration Agreement shall
control.

 

 

EXHIBIT D

DEVELOPMENT PLANS

(see attached)

 

 

SCHEDULE 7.2.1A

SEASONIQUE MILESTONE PAYMENTS

	 	 	 
	Event	 	Payment
	Filing of Drug Approval Application under EMEA for Seasonique

	 	$[*]
	Regulatory Approval under EMEA for Seasonique

	 	$[*]
	Filing of Drug Approval Application under EMEA for first new
indication for Seasonique

	 	$[*]
	Regulatory Approval under EMEA for first new indication for 

Seasonique

	 	$[*]
	First calendar year in which annual net sales in Shire Territory
for Seasonique exceed $50 million

	 	$[*]
	Second calendar year in which annual net sales in Shire Territory
for Seasonique exceed $100 million

	 	$[*]

 

 

SCHEDULE 7.2.1B

RING PRODUCT MILESTONE PAYMENTS

	 	 	 
	Event	 	Payment
	Successful completion of Phase I clinical trials for Ring Product

	 	$[*]
	Successful completion of Phase I clinical trials for Ring Product

	 	$[*]
	Successful completion of Phase III clinical trials for Ring Product

	 	$[*]
	Filing of Drug Approval Application under EMEA for Ring Product

	 	$[*]
	Regulatory Approval under EMEA for Ring Product

	 	$[*]
	First calendar year in which annual net sales in Shire Territory
for Ring Product exceed $50 million

	 	$[*]
	Second calendar year in which annual net sales in Shire Territory
for Ring Product exceed $100 million

	 	$[*]

 

 

SCHEDULE 13.3(b)

COLLABORATION PRODUCT INDs

[*]

[*]

[*]

[*]

[*]

[*]

 

 

Schedule 13.3(c)

	 	 	 	 	 	 	 	 	 
	Jurisdiction	 	Patent No.	 	Grant Date	 	Application No.	 	Filing Date
	[*]

	 	[*]
	 	[*]
	 	[*]
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	[*]

	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	 	[*]
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	[*]

	 	[*]
	 	[*]
	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	 	[*]
	 	[*]

 

 

EXHIBIT C

QUALITY AGREEMENT

 

 

EXHIBIT D

SAFETY AGREEMENT

 

 

SCHEDULE 1

FORM OF PURCHASE ORDER

 

 

SCHEDULE 2

FORM OF COAEX-10.3

 

     Pursuant to 17 CFR 240.24b-2, confidential information (indicated by [*])
has been omitted and has been filed separately with the Securities and Exchange
Commission pursuant to a Confidential Treatment Application filed with the
Commission.

Exhibit 10.3

PRODUCT ACQUISITION AND LICENSE AGREEMENT

(Adderall®)

BY AND AMONG

SHIRE LLC,

SHIRE PLC

AND

DURAMED PHARMACEUTICALS, INC.

DATED AS OF AUGUST 14, 2006

 

	 	 	 	 	 	 	 
	ARTICLE 1
	 	DEFINITION	 	 	1	 
	 
	 	 	 	 	 	 
	ARTICLE 2
	 	SALE OF ASSETS, LICENSES AND CLOSING	 	 	6	 
	 
	 	 	 	 	 	 
	2.1
	 	Sale of Assets	 	 	6	 
	 
	 	 	 	 	 	 
	2.2
	 	Licenses and Other Rights	 	 	8	 
	 
	 	 	 	 	 	 
	2.3
	 	[*]	 	 	8	 
	 
	 	 	 	 	 	 
	2.4
	 	Assumed Liabilities	 	 	8	 
	 
	 	 	 	 	 	 
	2.5
	 	Purchase Price	 	 	9	 
	 
	 	 	 	 	 	 
	2.6
	 	Independence of Purchase Price Obligation	 	 	9	 
	 
	 	 	 	 	 	 
	2.7
	 	Closing	 	 	9	 
	 
	 	 	 	 	 	 
	2.8
	 	Allocation of Purchase Price	 	 	9	 
	 
	 	 	 	 	 	 
	2.9
	 	Delivery of Purchased Assets	 	 	10	 
	 
	 	 	 	 	 	 
	ARTICLE 3
	 	REGULATORY MATTERS	 	 	10	 
	 
	 	 	 	 	 	 
	3.1
	 	Filings with Regulatory Authorities Regarding Transfer of Registrations	 	 	10	 
	 
	 	 	 	 	 	 
	3.2
	 	Responsibility for the Product	 	 	10	 
	 
	 	 	 	 	 	 
	3.3
	 	Marketing Activities	 	 	11	 
	 
	 	 	 	 	 	 
	3.4
	 	Right of Reference	 	 	11	 
	 
	 	 	 	 	 	 
	ARTICLE 4
	 	REPRESENTATIONS AND WARRANTIES	 	 	11	 
	 
	 	 	 	 	 	 
	4.1
	 	Representations and Warranties of Shire	 	 	11	 
	 
	 	 	 	 	 	 
	4.2
	 	Disclaimer of Warranties	 	 	14	 
	 
	 	 	 	 	 	 
	4.3
	 	Representations and Warranties of Duramed	 	 	14	 
	 
	 	 	 	 	 	 
	4.4
	 	Survival of Representations/Warranties	 	 	15	 
	 
	 	 	 	 	 	 
	4.5
	 	Brokers	 	 	15	 
	 
	 	 	 	 	 	 
	ARTICLE 5
	 	CONDITIONS TO CLOSING	 	 	16	 
	 
	 	 	 	 	 	 
	5.1
	 	Conditions to Obligations of Duramed	 	 	16	 
	 
	 	 	 	 	 	 
	5.2
	 	Conditions to Obligations of Shire	 	 	16	 
	 
	 	 	 	 	 	 
	ARTICLE 6
	 	COVENANTS	 	 	17	 
	 
	 	 	 	 	 	 
	6.1
	 	HSR Filing	 	 	17	 
	 
	 	 	 	 	 	 
	6.2
	 	Conduct of the Business Until Closing	 	 	18	 
	 
	 	 	 	 	 	 
	6.3
	 	Post-Closing Orders and Payments	 	 	18	 
	 
	 	 	 	 	 	 
	6.4
	 	Right to Investigate	 	 	18	 
	 
	 	 	 	 	 	 
	6.5
	 	Retention of Records	 	 	19	 
	 
	 	 	 	 	 	 
	6.6
	 	Non-Solicitation	 	 	19	 
	 
	 	 	 	 	 	 
	6.7
	 	Managed Markets	 	 	19	 

i

 

	 	 	 	 	 	 	 
	6.8
	 	Returns	 	 	20	 
	 
	 	 	 	 	 	 
	6.9
	 	Certain Sales	 	 	21	 
	 
	 	 	 	 	 	 
	ARTICLE 7
	 	INDEMNIFICATION	 	 	21	 
	 
	 	 	 	 	 	 
	7.1
	 	Indemnification by Shire	 	 	21	 
	 
	 	 	 	 	 	 
	7.2
	 	Indemnification by Duramed	 	 	21	 
	 
	 	 	 	 	 	 
	7.3
	 	Limitation of Liability	 	 	22	 
	 
	 	 	 	 	 	 
	7.4
	 	No Consequential Damages	 	 	22	 
	 
	 	 	 	 	 	 
	7.5
	 	Procedures for Indemnification for Third Party Claims	 	 	23	 
	 
	 	 	 	 	 	 
	7.6
	 	Losses That Are Not Third Party Claims	 	 	24	 
	 
	 	 	 	 	 	 
	7.7
	 	Termination of Indemnification Obligations	 	 	24	 
	 
	 	 	 	 	 	 
	7.8
	 	Other Matters	 	 	24	 
	 
	 	 	 	 	 	 
	7.9
	 	Other Limitations	 	 	25	 
	 
	 	 	 	 	 	 
	7.10
	 	Exclusive Remedy	 	 	25	 
	 
	 	 	 	 	 	 
	7.11
	 	Net Losses and Subrogation	 	 	26	 
	 
	 	 	 	 	 	 
	ARTICLE 8
	 	TERMINATION	 	 	26	 
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	8.1
	 	Termination Prior to Closing	 	 	26	 
	 
	 	 	 	 	 	 
	8.2
	 	Effect of Termination Prior to Closing	 	 	27	 
	 
	 	 	 	 	 	 
	ARTICLE 9
	 	PATENT PROSECUTION, MAINTENANCE AND ENFORCEMENT	 	 	27	 
	 
	 	 	 	 	 	 
	9.1
	 	Discretionary Duty to Maintain	 	 	27	 
	 
	 	 	 	 	 	 
	9.2
	 	Abandonment of Maintenance by Shire	 	 	27	 
	 
	 	 	 	 	 	 
	9.3
	 	Patent Marking	 	 	27	 
	 
	 	 	 	 	 	 
	9.4
	 	Suits for Infringement of the Licensed Patents	 	 	27	 
	 
	 	 	 	 	 	 
	ARTICLE 10
	 	DISPUTE RESOLUTION	 	 	28	 
	 
	 	 	 	 	 	 
	10.1
	 	Disputes	 	 	28	 
	 
	 	 	 	 	 	 
	10.2
	 	Litigation	 	 	28	 
	 
	 	 	 	 	 	 
	10.3
	 	Injunctive Relief	 	 	28	 
	 
	 	 	 	 	 	 
	ARTICLE 11
	 	GENERAL PROVISIONS	 	 	28	 
	 
	 	 	 	 	 	 
	11.1
	 	Payment of Transaction Expenses	 	 	28	 
	 
	 	 	 	 	 	 
	11.2
	 	Access to Information Post-Closing	 	 	28	 
	 
	 	 	 	 	 	 
	11.3
	 	Notices	 	 	29	 
	 
	 	 	 	 	 	 
	11.4
	 	Entire Agreement; Amendment	 	 	30	 
	 
	 	 	 	 	 	 
	11.5
	 	Assignment	 	 	30	 

ii

 

	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	11.6
	 	Headings	 	 	30	 
	 
	 	 	 	 	 	 
	11.7
	 	Independent Parties	 	 	30	 
	 
	 	 	 	 	 	 
	11.8
	 	No Waiver	 	 	30	 
	 
	 	 	 	 	 	 
	11.9
	 	Severability	 	 	30	 
	 
	 	 	 	 	 	 
	11.10
	 	Counterparts	 	 	31	 
	 
	 	 	 	 	 	 
	11.11
	 	No Third Party Beneficiaries	 	 	31	 
	 
	 	 	 	 	 	 
	11.12
	 	Further Actions	 	 	31	 
	 
	 	 	 	 	 	 
	11.13
	 	No Strict Construction	 	 	31	 
	 
	 	 	 	 	 	 
	11.14
	 	Public Disclosure	 	 	31	 
	 
	 	 	 	 	 	 
	11.15
	 	Bulk Sales Laws	 	 	31	 

iii

 

PRODUCT ACQUISITION AND LICENSE AGREEMENT

     THIS PRODUCT ACQUISITION AND LICENSE AGREEMENT is dated as of August 14, 2006, by and among
Shire LLC, a Kentucky limited liability company (together with its Affiliates, “Shire”), Shire plc
a British public limited company, and Duramed Pharmaceuticals, Inc., a corporation organized and
existing under the laws of Delaware (“Duramed”). Shire and Duramed are sometimes referred to
herein individually as a “Party” and together as the “Parties”.

RECITALS

     WHEREAS, Shire is in the business of formulating, manufacturing, marketing and distributing
the pharmaceutical product known as Adderall IR®;

     WHEREAS, Shire owns the pharmaceutical product known as Adderall IR® and all the assets
relating to the Adderall Business; and

     WHEREAS, Shire desires to sell, transfer, convey and license to Duramed, and Duramed desires
to purchase, acquire and license from Shire, certain rights to the Adderall IR® product and certain
assets relating to the Adderall Business, and Duramed wishes to assume certain liabilities relating
to such product, all on the terms set forth herein;

     NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in this
Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties hereto hereby agree as follows:

ARTICLE 1

DEFINITIONS

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

     1.1 “Act” means the United States Federal Food, Drug and Cosmetic Act, as amended.

     1.2 “Adderall Business” means the business of formulating, manufacturing, and distributing the
pharmaceutical product known as Adderall IR®; provided, however, that the Adderall Business shall
not include any Adderall product other than the Product, including Adderall XR or [SPD465].

     1.3 “Adderall XR” means the extended release mixed amphetamine pharmaceutical product
currently sold under NDA#21-303.

     1.4 “Affiliate” means a Person that, directly or indirectly, through one or more
intermediates, controls, is controlled by, or is under common control with, the Person specified.
For the purposes of this definition, control shall mean the direct or indirect ownership of (a) in
the case of corporate entities, securities authorized to cast more than fifty percent (50%) of the
votes in any election for directors, (b) in the case of non-corporate entities, more than fifty

 

percent (50%) ownership interest with the power to direct the management and policies of such
non-corporate entity, or (c) such lesser percentage as may be the maximum percentage allowed to be
owned by a foreign corporation under the applicable laws or regulations of a particular
jurisdiction of the equity having the power to vote in the election of directors or to direct the
management and policies of such Person.

     1.5 “Agreement” means this Agreement and all exhibits and schedules attached hereto.

     1.6 “Books and Records” means all books, records, manuals and other materials (in any form or
medium) relating primarily to the Purchased Assets or the Adderall Business, including all records
and materials maintained at the headquarters of Shire, advertising matter, catalogues, price lists
(including any pricing for the Product made available to any Federal, State or local authorities),
correspondence, mailing lists, lists of customers, distribution lists, photographs, production
data, sales and promotional materials and records, purchasing materials and records, manufacturing
and quality control records and procedures, blueprints, research and development files, records,
data and laboratory books, accounting records, and sales order files.

     1.7 “Business Day” means any day except a Saturday, Sunday or a day on which a commercial bank
in New York, New York is authorized to close.

     1.8 “Duramed Labeled Product” means Product sold or distributed after the Closing by or on
behalf of Duramed bearing the NDC number of Duramed or any of its Affiliates.

     1.9 “Duramed Material Adverse Effect” means any adverse change, circumstance or effect that,
individually or in the aggregate with all other adverse changes, circumstances and effects, has or
is reasonably likely to have, a material adverse effect on the ability of Duramed to consummate the
transactions contemplated by this Agreement, including the ability to pay the Purchase Price when
due.

     1.10 “Contract” means any agreement, contract, commitment or other instrument or arrangements
(whether written or oral) (x) by which any of the Purchased Assets are bound or affected or (y) to
which Shire is bound relating to the Purchased Assets, in each case as amended, supplemented,
waived or otherwise modified.

     1.11 “Excluded Intellectual Property” means the (a) Shire Trademark, (b) Product Trademark,
(c) Licensed Patents, (d) Product Trade Dress, and (e) Intellectual Property that does not
primarily relate to the Product.

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

     1.13 “Finished Goods” means a manufactured Product packaged and ready for sale to the ultimate
customer in the Territory.

     1.14 “Governmental Authority” means any federal, state, local or other government or any court
of competent jurisdiction, legislature, governmental agency, administrative agency

- 2 -

 

or commission or other governmental authority or instrumentality having jurisdiction in the
Territory.

     1.15 “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

     1.16 “Intellectual Property” means all (a) Patents, (b) mask works and copyrights in works of
authorship of any type, including computer software and industrial designs, registrations and
applications for registration thereof, (c) trademark registrations and applications for
registration thereof, (d) trade secrets, know-how and other confidential or proprietary technical,
business and other information, and all rights in any jurisdiction to limit the use or disclosure
thereof, and (e) rights to sue and recover damages or obtain injunctive relief for past and future
infringement, dilution, misappropriation, violation or breach thereof; in each case, solely to the
extent the foregoing relates to the Territory.

     1.17 “Liabilities” means any and all debts, liabilities and obligations, whether accrued or
fixed, absolute or contingent, matured or unmatured, or determined or determinable, including those
arising under any laws, action or governmental order and those arising under any contract,
agreement, arrangement, commitment or undertaking, or otherwise.

     1.18 “Licensed Patents” mean the Patent(s) listed in Schedule 1.18.

     1.19 “Lien” means any mortgage, pledge, hypothecation, right of others, claim, security
interest, encumbrance, lease, sublease, license, occupancy agreement, adverse claim or interest,
easement, covenant, encroachment, burden, title defect, title retention agreement, voting trust
agreement, interest, equity, option, lien, , whether arising by Contract or otherwise.

     1.20 “Losses” means any and all Liabilities, damages, fines, penalties, deficiencies, losses
and expenses (including interest, court costs, amounts paid in settlement, reasonable fees of
attorneys, accountants and other experts or other reasonable expenses of litigation or other
proceedings or of any claim, default or assessment); provided, however, that the term “Losses”
shall not include any special, consequential, indirect, punitive or similar damages, except to the
extent actually paid by a Party pursuant to any Third Party Claim.

     1.21 “NDA” means a New Drug Application pursuant to Section 505 of the Act (21 U.S.C. Section
355) submitted to the FDA or any successor application or procedure.

     1.22 “Patents” means all patents, patent applications and statutory invention registrations,
including reissues, divisions, continuations, continuations-in-part, supplementary protection
certificates, extensions and reexaminations thereof, all inventions disclosed therein, all rights
therein provided by international treaties and conventions, and all rights to obtain patents and
registrations thereto.

     1.23 “Permitted Liens” means (i) Liens for Taxes not yet due and payable or which are being
contested in good faith and by appropriate proceedings if adequate reserves with respect thereto
are maintained on Shire’s books or (ii) Liens that, individually and in the aggregate, do not
restrict, hinder, or otherwise encumber or impair the ownership of or right to use the Purchased
Assets or sell of Product.

- 3 -

 

     1.24 “Person” means any individual, firm, corporation, partnership, limited liability company,
trust, unincorporated organization or other entity or a government agency or political subdivision
thereto, and shall include any successor (by merger or otherwise) of such Person.

     1.25 “Pharmacovigilance Agreement” means the Pharmacovigilance Agreement to be executed at
Closing by Shire and Duramed substantially in the form attached hereto as Exhibit A.

     1.26 “Product” means the pharmaceutical product in all dosage forms identified in [*].

     1.27 “Product Domain Name” means the domain name “adderall.com” and all other domain names
that include “Adderall” in any manner or form and that are owned or registered by Shire.

     1.28 “Product Material Adverse Effect” means any adverse event, circumstance, fact, condition
or effect that is materially adverse to the operations or results of operation, properties or
prospects of the Adderall Business, the Purchased Assets, the Licenses, or the Product Trademark,
other than any event, change, circumstance or effect relating to (a) the economy of the United
States in general, (b) in general to the industries in which the Product is sold and not
specifically relating to the Product, or (c) changes, circumstances and effects relating to the
announcement of the transactions contemplated by this Agreement.

     1.29 “Product NDA” means NDA#11-522, and any and all supplements or amendments filed pursuant
to FDA requirements.

     1.30 “Product Trade Dress” means the tablet logo, including the lettering of the Product name
and, specifically, the letters “AD”, the size, shape and color of the tablet, together with all
other features that are intrinsic to the tablet as currently marketed and sold, provided that
Product Trade Dress does not include any packaging associated with the sale, marketing or
distribution of the Product.

     1.31 “Product Trademark” means the trademark, trade names, brand names, including all
registrations and applications for registration thereof and all renewals, modifications and
extensions thereof, listed on Schedule 1.31, used by Shire or its Affiliates in connection
with the manufacture, marketing, sale and distribution of the Product, and any rights existing
under common law relating thereto.

     1.32 “Regulatory Approval” means the technical, medical and scientific licenses,
registrations, authorizations, approvals, permits, consents (including approvals of NDAs,
supplements and amendments, pre- and post- approvals, pricing and third party reimbursement
approvals, and labeling approvals) of any Regulatory Authority necessary for the development
(including the conduct of clinical trials), distribution, marketing, promotion, offer for sale,
use, import, export or sale of Product in the Territory.

     1.33 “Regulatory Authority” means any national (e.g., the FDA), regional, state or
local regulatory agency, department, bureau, commission, council, court or other Governmental
Authority in the Territory.

- 4 -

 

     1.34 “Settlement Agreement” means that certain Settlement Agreement, dated as of August 14,
2006, by and between the Parties.

     1.35 “Shire Labeled Product” means Product bearing the NDC number of Shire or any of its
Affiliates.

     1.36 “Shire Trademark” means the “Shire” name or any variation thereof and, other than the
Product Trade Dress, the Product Trademark and the Product Domain Name, all trademarks, trade
names, brand names, trade dress, logo types, symbols, domain names (including registrations and
applications for registration thereof and all renewals, modifications and extensions thereof) used
by Shire or its Affiliates in connection with the manufacture, marketing, sale and distribution of
their products.

     1.37 “Supply Agreement” means the Supply Agreement to be executed at Closing by Shire or its
Affiliate and Duramed for the supply of Product, in substantially the form attached hereto as
Exhibit C.

     1.38 “Survival Period” means the period of survival of representations and warranties as set
forth in Section 4.4.

     1.39 “Taxes” (and with correlative meaning, “Tax,” “Taxes,” and “Taxable”) shall mean all
taxes of any kind imposed by a federal, state, local or foreign Governmental Authority, including
those on, or measured by or referred to as, income, gross receipts, financial operation, sales,
use, ad valorem, value added, franchise, profits, license, excise, stamp, premium, property,
transfer or windfall profits taxes, customs, duties or similar fees, assessments or charges of any
kind whatsoever, together with any interest and any penalties, additions to tax or additional
amounts imposed by such Governmental Authority with respect to such amounts.

     1.40 “Technical Data” means all technical, scientific, chemical, biological, pharmacological,
and toxicological data generated primarily for the Product.

     1.41 “Territory” means the United States and the states, territories, possessions and
protectorates thereof, the District of Columbia and the Commonwealth of Puerto Rico.

     1.42 “Trademark License Agreement” means the Trademark License Agreement to be executed at
Closing by Shire or its Affiliate and Duramed relating to the use of the Product Trademark, in
substantially the form attached hereto as Exhibit B.

Interpretation. Unless the context of this Agreement otherwise requires, (a) words of one gender
include the other gender; (b) words using the singular or plural number also include the plural or
singular number, respectively; (c) the terms “hereof,” “herein,” “hereby,” and other similar words
refer to this entire Agreement; (d) “including” shall be deemed followed by “without limitation”,
“but not limited to” or words of similar meaning; and (e) the terms “Article” and “Section” refer
to the specified Article and Section of this Agreement. Whenever this Agreement refers to a number
of days, unless otherwise specified, such number shall refer to calendar days.

- 5 -

 

Additional Definitions. Each of the following definitions is set forth in the Section of this
Agreement indicated below:

	 	 	 
	Acquisition Transaction

	 	Section 6.6(b)
	AMP

	 	Section 6.7(b)
	Assumed Liabilities

	 	Section 2.4(a)
	Chargeback Contracts

	 	Section 6.7(e)
	Chargebacks

	 	Section 6.7(a)
	Closing

	 	Section 2.7(a)
	Closing Date

	 	Section 2.7(a)
	Duramed

	 	Preamble
	Duramed Disclosure Schedule

	 	Section 4.3
	Defaulting Party

	 	Section 8.1(c)
	DMFs

	 	Section 3.4
	Excluded Assets

	 	Section 2.1(c)
	FDA Letter

	 	Section 3.1
	Financial Information

	 	Section 4.1(d)
	General
Assignment and Assumption

	 	 Section 2.7(c)
	Indemnitee

	 	Section 7.5(a)
	Indemnitor

	 	Section 7.5(a)
	Licenses

	 	Section 2.2(a)
	Managed Market Activities

	 	Section 6.7(a)
	Parties

	 	Preamble
	Party

	 	Preamble
	Purchase Price

	 	Section 2.5
	Purchased Assets

	 	Section 2.1(a)
	Rebate Contracts

	 	Section 6.7(d)
	Rebates

	 	Section 6.7(a)
	Representatives

	 	Section 10.1
	Retained Liabilities

	 	Section 2.4(b)
	SEC

	 	Section 11.14(a)
	Shire

	 	Preamble
	Shire Disclosure Schedule

	 	Section 4.1
	Third Party Claim

	 	Section 7.5(a)
	Transaction Agreements

	 	Section 11.4

ARTICLE 2

SALE OF ASSETS, LICENSES AND CLOSING

     2.1 Sale of Assets.

          (a) On the Closing Date, and subject to the terms and conditions of this Agreement, Shire
will, and will cause its Affiliates to, sell, assign, convey and transfer to Duramed, and Duramed
will purchase and accept from Shire and its Affiliates, all of Shire’s and its Affiliates’ right,
title and interest in and to the following assets (collectively, the “Purchased Assets”):

- 6 -

 

               (i) the Product NDA;

               (ii) the Book and Records; provided that any lists included therein may be redacted as
necessary to conceal information pertaining to products other than the Product;

               (iii) the Technical Data;

               (iv) all unfulfilled customer orders for the Product arising in the Territory as of the
Closing Date (a list of such orders to be provided to Duramed on or prior to the Closing) and any
future customer orders received by Shire for the Product;

               (v) to the extent their transfer is permitted by law, all Regulatory Approvals, including all
applications therefor;

               (vi) all refunds or credit of Taxes relating to the foregoing attributable to any period
following the Closing;

               (vii) any guarantees, warranties, indemnities and similar rights in favor of Shire or its
Affiliates with respect to any of the foregoing; and

               (viii) all rights to causes of action, lawsuits, judgments, claims and demands of any nature
available to or being pursued by Shire or its Affiliates with respect to the Adderall Business or
the ownership, use, function or value of any of the foregoing, whether arising by way of
counterclaim or otherwise.

          (b) Notwithstanding Section 2.1(a) above, the transfer of the Product NDA shall occur in
accordance with the provisions of Article 3.

          (c) For purposes of clarification, the Purchased Assets shall not include any assets, rights
or interests other than those specifically listed or described in Section 2.1(a). Without limiting
the generality of the foregoing, the Parties agree and acknowledge that the Purchased Assets shall
not include: (i) the Excluded Intellectual Property, (ii) any and all NDAs or other product
approvals and Technical Data related to Adderall XR or anything else related to the approval, sale,
marketing or manufacturing of Adderall XR, (iii) any Adderall product other than the Product, and
(iv) any plant, real property, equipment, accounts receivable, cash and cash equivalents, employees
or any refund or credit of Taxes attributable to any period of time prior to the Closing Date
(collectively, the “Excluded Assets”). Duramed acknowledges and agrees that Shire may retain a
copy of all or part of the Books and Records that it delivers to Duramed under Section 2.1(a)(ii)
for use with products of Shire or its Affiliates other than the Product or to the extent required
under applicable law provided that the copy of the Books and Records so retained shall be treated
as Duramed’s confidential information.

     2.2 Licenses and Other Rights.

          (a) Subject to the terms and conditions of this Agreement, Shire hereby grants, or shall cause
its Affiliates to grant, to Duramed the following licenses (collectively, the “Licenses”):

- 7 -

 

               (i) a worldwide, irrevocable, perpetual, fully-paid, exclusive (even as to Shire) right and
license, with the right to sublicense under the Licensed Patents, to use, market, have marketed,
offer for sale, import for sale, sell and have sold Products in the Territory;

               (ii) an irrevocable, fully-paid, perpetual, exclusive (even as to Shire) right and license
under the Product Trade Dress solely to the extent necessary for Duramed to distribute, market and
sell the Product in the Territory.

          (b) With respect to this Agreement, any Intellectual Property or other rights of Shire not
expressly granted to Duramed under the provisions of this Agreement shall be retained by Shire,
including the right to conduct such studies and clinical trials within and without the Territory as
may be necessary or useful for Shire to obtain Regulatory Approvals solely for the purpose of
selling products other than Product.

     2.3 [*]. From and after the Closing Date, Shire [*] Duramed or its Affiliates [*] Duramed’s
[*] Product in the Territory on the basis that such [*] Shire or of [*] as of the Closing Date or
[*].

     2.4 Assumed Liabilities.

          (a) As of the Closing Date, Duramed shall assume, be responsible for and pay, perform and
discharge when due the following (collectively, the “Assumed Liabilities”):

               (i) any Liabilities arising from the sale of any Product after the Closing Date, including any
product liability, breach of warranty, Patent or trademark infringement claim, or any other action
or claim (excluding any Liabilities relating to voluntary or involuntary recalls of Shire Labeled
Product, or any Liabilities of Shire under the Supply Agreement) brought, asserted or filed by any
third party or Regulatory Authority;

               (ii) any Liabilities arising after the Closing Date relating to the Purchased Assets;

               (iii) subject to Section 6.7, all Medicare, Medicaid and state program rebates in connection
with Duramed Labeled Product sold after the Closing Date;

               (iv) subject to Section 6.7, all chargebacks, rebates or any other post-sale rebates, refunds,
price adjustments and other similar payments, credits or liabilities in connection with the Duramed
Labeled Product, sold after the Closing Date; and

               (v) subject to Section 6.7, credits, utilization based rebates, reimbursements, and similar
payments to buying groups, insurers and other institutions in connection with Duramed Labeled
Product sold after the Closing Date.

          (b) Notwithstanding any provision hereof or any schedule or exhibit hereto or thereto, and
regardless of any disclosure to Duramed, Duramed shall not assume any liabilities, obligations or
commitments of Shire other than the Assumed Liabilities, including such liabilities

- 8 -

 

           relating to or arising out of the ownership of the Purchased Assets on or prior to the Closing
(the “Retained Liabilities”).

     2.5 Purchase Price. Subject to the terms and conditions set forth herein, in consideration of
the sale, assignment, conveyance, license and delivery of the Purchased Assets and the Licenses,
and as consideration for the execution and delivery of the Trademark License Agreement, Duramed
will pay to Shire a cash payment of Sixty-Three Million Dollars ($63,000,000), in the manner
described in Section 2.7(b), (the “Purchase Price”).

     2.6 Independence of Purchase Price Obligation. All payments made or to be made by Duramed to
Shire in respect of Purchase Price shall be non-refundable and independent of any obligations that
Shire or its Affiliates may have to Duramed under any other agreement.

     2.7 Closing.

          (a) The closing of the transactions contemplated hereby (the “Closing”) will take place at the
offices of Morgan, Lewis & Bockius LLP in Princeton, New Jersey at 10:00 A.M. Eastern Time on the
third (3rd) Business Day following the satisfaction or waiver of all conditions or obligations of
the Parties set forth in Sections 5.1 and 5.2, or at such other time, date and place as Duramed and
Shire agree. The actual date of the Closing is referred to as the “Closing Date.”

          (b) At the Closing, Duramed will pay the Purchase Price in full in cash without any deductions
or offsets by wire transfer of immediately available funds to a bank account or accounts to be
designated by Shire prior to Closing.

          (c) At the Closing, Shire will assign and transfer to Duramed all of Shire’s right, title and
interest in and to the Purchased Assets, by delivery of a general assignment, assumption and bill
of sale in the form of Exhibit D (the “General Assignment and Assumption”) or any other
bill of sale or assignment documents reasonably requested by Duramed.

          (d) At the Closing, Duramed will assume from Shire the due payment, performance and discharge
of the Assumed Liabilities by delivery of the General Assignment and Assumption.

          (e) At or prior to the Closing, the Parties shall execute and deliver to one another the
agreements listed in Sections 5.1(h) and 5.2(h).

     2.8 Allocation of Purchase Price. The Purchase Price shall be allocated among the Purchased
Assets, the Licenses, the Trademark License Agreement and the Supply Agreement as set forth on
Schedule 2.8 hereto. Duramed and Shire agree to report the sale and purchase of the
Purchased Assets, and the rights granted or assets transferred under the Licenses and the Trademark
License Agreement for Tax purposes in accordance with the allocations set forth on Schedule
2.8 hereto, or as otherwise agreed to at a later date by the Parties if such Schedule is not
attached as of the Closing Date.

- 9 -

 

     2.9 Delivery of Purchased Assets. At the Closing or as soon as possible thereafter, Shire
shall deliver to Duramed, all of the Purchased Assets. Following the Closing, Shire shall
reasonably cooperate with Duramed and grant to Duramed and its employees, attorneys, accountants,
officers, representatives, and agents, reasonable access to Shire’s personnel to fully transfer and
disclose to Duramed all of the Purchase Assets.

ARTICLE 3

REGULATORY MATTERS

     3.1 Filings with Regulatory Authorities Regarding Transfer of Registrations. Prior to
Closing, Shire and Duramed will establish a mutually acceptable and prompt communication and
interaction process to ensure to Duramed the prompt and orderly transfer of the Product NDA.
Promptly after Closing, the Parties shall file with the FDA and any other relevant Regulatory
Authorities all information required in order to transfer the Product NDA from Shire to Duramed,
including the letter to the FDA authorizing the transfer in the form attached hereto as Exhibit
E (the “FDA Letter”). Where required, Duramed shall also promptly file an application or
license variation to Regulatory Authorities or other government/health agencies. Shire shall file
the information required of a former owner, and Duramed shall file the information required of a
new owner, at each Party’s own expense. Both Duramed and Shire also agree to use all commercially
reasonable efforts to take any actions required by the Regulatory Authorities or other
government/health agencies to effect the transfer of the Product NDA from Shire to Duramed, and
hereby further agree to cooperate with each other in order to effectuate the foregoing transfer of
Product NDA at Duramed’s expense. The Parties agree to use all commercially reasonable efforts to
complete the filing of the transfer of the Product Registrations within [*] from the Closing Date.
Shire may retain an archival copy of the Product Registrations, including supplements and records
that are required to be kept under 21 C.F.R. §314.81, but such retention shall not be deemed a
license to Shire of such information nor be deemed to constitute any Shire ownership interest
therein.

     3.2 Responsibility for the Product. From and after the Closing Date, and in no event later
than the effective date of the transfer to Duramed of the applicable NDA, Duramed shall assume all
regulatory responsibilities under applicable laws in connection with the Product and the Product
NDA, including (a) responding to all medical inquiries, (b) responsibility for reporting any
adverse drug events in connection with the Product, (c) responsibility for compliance with the
Prescription Drug Marketing Act of 1987, as the same may be amended from time to time, and (d)
responsibility for any and all fee obligations for holders or owners of approved NDAs and
Regulatory Approvals relating to the Product, including those defined under the Prescription Drug
User Fee Act of 1992, as the same may be amended from time to time. In connection therewith, Shire
shall promptly after Closing deliver to Duramed all records, documentation and other information
that Shire has prepared or has had prepared regarding the development, efficacy, safety and legal
compliance of the Product, including all correspondence with Regulatory Authorities or other
government/health agencies related to the Product. Shire acknowledges that pursuant to the terms
of the Pharmacovigilance Agreement, Shire shall be responsible for compliance with certain of the
foregoing obligations following the Closing. Without limiting Shire’s obligations under the
Pharmacovigilance Agreement, Shire shall cooperate with Duramed following the Closing to provide
reasonable assistance in connection with Duramed’s regulatory obligations related to the Product
for a period of [*].

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     3.3 Marketing Activities. Immediately following the Closing, Shire and Duramed shall send
correspondence to each customer and supplier of the Product, and any other relevant third party
agreed to by Shire and Duramed, informing each such party of the sale and transfer of the Product
to Duramed, in substantially the form attached hereto as Exhibit F.

     3.4 Right of Reference. Duramed shall grant Shire a right of cross-reference or right of
reference, including as that term is defined in 21 C.F.R. Section 314.3(b), to all existing
Regulatory Approvals, Drug Master Files (“DMFs”), and other regulatory submissions relating to the
Product. At Shire’s request [*], Duramed shall provide a copy of any regulatory application or
file relating to Product that is the subject of a right of cross-reference or right of reference
pursuant to this Section.

ARTICLE 4

REPRESENTATIONS AND WARRANTIES

     4.1 Representations and Warranties of Shire. Shire represents and warrants to Duramed solely
as of the date of this Agreement, subject to such exceptions as are specifically disclosed in the
disclosure schedule supplied by Shire to Duramed and dated as of the date hereof (the “Shire
Disclosure Schedule”) as follows:

          (a) Organization and Standing. Shire is a corporation duly organized, validly existing and in
good standing under the laws of the jurisdiction of its formation, with full corporate power and
authority to carry on the Adderall Business and to own or lease and to operate its properties in
the places where such business is conducted and such properties are owned, leased or operated.

          (b) Power and Authority. Shire has all requisite corporate power and authority to execute,
deliver, and perform this Agreement, and the other Transaction Agreements, and the other agreements
and instruments to be executed and delivered by it pursuant hereto and thereto, and to consummate
the transactions contemplated herein and therein.

          (c) No Conflicts. The execution, delivery and performance by Shire of this Agreement and the
other Transaction Agreement, and the consummation of the transactions contemplated hereby and
thereby, do not and will not conflict with or result in a violation of or a default under (with or
without the giving of notice or the lapse of time or both) (i) any applicable law, (ii) the
certificate of incorporation or by-laws or other organizational documents of Shire, or (iii) any
Contract or other contract, agreement, instrument, judgment, order or decree to which Shire is a
party or by which Shire may be bound or affected.

          (d) Financial Information. Shire has provided to Duramed [*], and for the [*] (“Financial
Information”). Such information was derived from the books and records of Shire and was prepared
by Shire in good faith and fairly presents, in all material respects, the sales of Product in the
Territory for the periods shown. No representations or warranties whatsoever are made with respect
to any financial projections.

          (e) Corporate Action; Binding Effect. Shire has duly and properly taken all action required
by law, its organizational documents, or otherwise, to authorize the execution, delivery, and
performance by it of this Agreement, the other Transaction Agreements, and the

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           other agreements and instruments to be executed and delivered by it pursuant hereto and
thereto and the consummation of transactions contemplated hereby and thereby. This Agreement has
been duly executed and delivered by Shire and constitutes, and the other Transaction Agreements and
the other agreements and instruments contemplated hereby and thereby when duly executed and
delivered by Shire will constitute, legal, valid, and binding obligations of Shire enforceable
against it in accordance with their respective terms, except as enforcement may be affected by
bankruptcy, insolvency, or other similar laws and by general principles of equity.

          (f) Consents. No consent or approval of, or filing with or notice to, any Regulatory
Authority or Governmental Authority is required or necessary to be obtained by Shire or on its
behalf in connection with the execution, delivery, and performance of this Agreement or to
consummate the transactions contemplated hereby and thereby, except (i) in connection with the
transfer of the Product Registrations, (ii) the notification requirements of the HSR Act, or
(iii) as relates solely to Duramed.

          (g) Assets.

               (i) Shire or one of its Affiliates owns and has good and marketable title to all the Purchased
Assets, in each case free and clear of any and all Liens other than Permitted Liens.

               (ii) Except for Excluded Assets, there are no assets or properties used in the operation of
the Adderall Business and owned by any Person other than Shire that will not be sold or licensed to
Duramed hereunder. The Purchased Assets [*] for the [*] or are [*], and [*] and, [*] Shire [*] the
Purchased Assets [*] or in the [*] with the [*].

          (h) Litigation or Disputes. Except as set forth on Schedule 4.1(h), there is no
claim, action, suit, demand, citation, grievance, subpoena, inquiry, proceeding, investigation, or
arbitration relating to the Product, the Purchased Assets or the Adderall Business pending or, to
Shire’s knowledge, threatened against Shire or any of its Affiliates by or before any Regulatory
Authority, federal, state, or other governmental court, department, commission, or board (whether
domestic or foreign). Except as set forth on Schedule 4.1(h), there is not currently
outstanding against Shire or any of its Affiliates any judgment, decree, injunction, rule or order
of any Regulatory Authority or Governmental Authority relating to the Purchased Assets or the
Adderall Business.

               (i) Licensed Patents, Technical Data and Other Intellectual Property.

               (i) Shire owns or has the lawful right and license to use the Licensed Patents.

               (ii) Shire has not received any written notice, and Shire otherwise has no knowledge of, the
infringement by any Person of any Licensed Patent or the Technical Data.

               (iii) Shire owns all of the Technical Data. The Technical Data contains all of the technical,
scientific, chemical, biological, pharmacological and toxicological data generated by Shire for the
Product.

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               (iv) Shire has the full right, power and authority to grant the Licenses as described herein.

               (v) The Licensed Patents have been duly registered with, filed in or issued by, as the case
may be, the United States Patent and Trademark Office and the Canadian Intellectual Property
Office.

               (vi) No claim or demand of any Person has been made nor is there any proceeding that is
pending, or to the knowledge of Shire, threatened, which (i) challenges the rights of Shire in
respect of the Licensed Patents, Technical Data, Product Trademark or Product Trade Dress or (ii)
asserts that Shire or any of its Affiliates is infringing, or is otherwise in conflict with, or is
required to pay any royalty, license fee, charge or other amount with regard to, any such
Intellectual Property of any third party. None of the Licensed Patents, Technical Data, Product
Trademark or Product Trade Dress is subject to any outstanding order, ruling, decree, judgment or
stipulation by or with any court, arbitrator, or administrative agency. To Shire’s knowledge, the
sale of the Product does not infringe or otherwise conflict with any rights of any Person in
respect of any Intellectual Property.

          (j) Compliance with Laws. Shire has conducted its operations in connection with the Purchased
Assets and the manufacture and sale of the Product in the Territory in material compliance with all
applicable laws. Except as set forth on Schedule 4.1(j), Shire has not received any
written notice of violation of any applicable law from any Regulatory Authority or Governmental
Authority relating to the Adderall Business, the Purchased Assets or the Product within the past
[*].

          (k) Regulatory Issues. Except as set forth in Schedule 4.1(k), during the [*] prior
to the date of this Agreement, with respect to the Product in the Territory, the Purchased Assets
or the Adderall Business, neither Shire nor any of its Affiliates has received or been subject to
(i) any FDA Form 483’s relating to the Product, (ii) any FDA Notices of Adverse Findings relating
to the Product, or (iii) any warning letters or other written correspondence from the FDA or any
other Regulatory Authority concerning the Product in which the FDA or such other Regulatory
Authority asserted that the operations of Shire were not in compliance with applicable law, with
respect to the Product or the Adderall Business. Except as discussed in Schedule 4.1(k) or
as would not have a Product Material Adverse Effect, during the last [*] there has not been any
occurrence of any product recall, market withdrawal or replacement, or post-sale warning conducted
by or on behalf of Shire concerning the Product, any product recall, market withdrawal or
replacement conducted by or on behalf of any entity as a result of any alleged defect in the
Product or the Technical Data.

          (l) Product Warranties. Except for warranties arising solely pursuant to applicable law, (i)
Shire has not made any warranties express or implied, written or oral, to any third party with
respect to the Product and (ii) there are no pending or threatened claims with respect to any such
warranty, and except for the warranties arising solely pursuant to applicable law, Shire has no any
liability with respect to any such warranty, whether known or unknown, absolute, accrued,
contingent or otherwise and whether due or to become due.

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          (m) Taxes. There are no Liens for Taxes upon the Purchased Assets or the rights granted under
the Licenses except for Permitted Liens. None of the Purchased Assets is “tax-exempt use property”
within the meaning of Section 168 of the Code.

          (n) Other. In the past [*], to Shire’s knowledge (i) there has not been a Product Material
Adverse Effect that is not otherwise generally known to the public, and (ii) the Product has been
distributed by Shire only in the United States.

     4.2 Disclaimer of Warranties. EXCEPT AS EXPRESSLY PROVIDED HEREIN, SHIRE PROVIDES THE
PURCHASED ASSETS AND LICENSES “AS IS” AND SHIRE DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
WITH REGARD TO THE PURCHASED ASSETS AND THE LICENSES, INCLUDING THE WARRANTY OF MERCHANTABILITY AND
THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

     4.3 Representations and Warranties of Duramed. Duramed represents and warrants to Shire,
subject to such exceptions as are specifically disclosed in the disclosure schedule supplied by
Duramed to Shire and dated as of the date hereof (the “Duramed Disclosure Schedule”), as follows:

          (a) Organization and Standing. Duramed is a corporation duly organized, validly existing and
in good standing under the laws of the jurisdiction of its formation.

          (b) Power and Authority. Duramed has all requisite corporate power and authority to execute,
deliver, and perform this Agreement, and the other Transaction Agreements, and the other agreements
and instruments to be executed and delivered by it pursuant hereto and thereto, and to consummate
the transactions contemplated herein and therein.

          (c) No Conflicts. The execution, delivery and performance by Duramed of this Agreement and
the other Transaction Agreement, and the consummation of the transactions contemplated hereby and
thereby, do not and will not conflict with or result in a violation of or a default under (with or
without the giving of notice or the lapse of time or both) (i) any law applicable to Duramed, (ii)
the certificate of incorporation or by-laws or other organizational documents of Duramed or (iii)
except as set forth in Section 4.3(c) of Duramed Disclosure Schedule, any Contract or other
contract, agreement, instrument, judgment, order or decree to which Duramed is a party or by which
Duramed may be bound or affected, except in the case of clauses (iii), as would not have a Duramed
Material Adverse Effect.

          (d) Corporate Action; Binding Effect. Duramed has duly and properly taken all action required
by law, its organizational documents, or otherwise, to authorize the execution, delivery, and
performance by it of this Agreement, the other Transaction Agreements, and the other agreements and
instruments to be executed and delivered by it pursuant hereto and thereto and the consummation of
transactions contemplated hereby and thereby. This Agreement has been duly executed and delivered
by Duramed and constitutes, and the other Transaction Agreements and the other agreements and
instruments contemplated hereby and thereby when duly executed and delivered by Duramed will
constitute, legal, valid, and binding obligations of Duramed enforceable against it in accordance
with their respective terms, except as enforcement

- 14 -

 

           may be affected by bankruptcy, insolvency, or other similar laws and by general principles of
equity.

          (e) Litigation or Disputes; Compliance with Laws. There is no claim, action, suit, demand,
citation, grievance, subpoena, inquiry, proceeding, investigation, or arbitration pending or, to
Duramed’s knowledge, threatened against Duramed by or before any Regulatory Authority, federal,
state, or other governmental court, department, commission, or board (whether domestic or foreign)
and, to Duramed’s knowledge, Duramed is not in violation of or in default with any applicable law,
the result of any of which, either individually or cumulatively, would have a Duramed Material
Adverse Effect.

          (f) Consents. No consent or approval of, or filing with or notice to, any Regulatory
Authority or Governmental Authority is required or necessary to be obtained by Duramed in
connection with the execution, delivery, and performance of this Agreement or the other Transaction
Agreements or to consummate the transactions contemplated hereby and thereby, except (i) in
connection with the transfer of the Product Registrations, (ii) the notification requirements of
the HSR Act or (iii) as relates solely to Shire.

          (g) Financing. As of the date of this Agreement, Duramed has access to, and as of the Closing
Date, Duramed will have, sufficient funds necessary to pay the Purchase Price.

     4.4 Survival of Representations/Warranties. All of the representations and warranties of
Shire contained in Section 4.1 shall survive the Closing and continue in full force and effect for
a period of [*] thereafter, provided that (a) all representations and warranties provided in
Sections 4.1(b), 4.1(c), 4.1(f), and 4.1(g), shall survive [*] and (b) the representations and
warranties set forth in Section 4.1(m) shall survive until [*] after the end of the applicable
statute of limitations. All of the representations and warranties set forth of Duramed contained
in Section 4.3 shall survive the Closing and continue in full force and effect for a period of [*]
thereafter, provided that all representations and warranties provided in Sections 4.3(b), 4.3(c),
4.3(d) and 4.3(f) shall survive [*].

     4.5 Brokers. Each Party represents that no agent, broker, investment banker, financial
advisor or other Person, is or will be entitled to any brokers’ or finder’s fee or any other
commission or similar fee in connection with this Agreement or any of the transactions contemplated
hereby.

ARTICLE 5

CONDITIONS TO CLOSING

     5.1 Conditions to Obligations of Duramed. The obligations of Duramed hereunder to consummate
the transactions contemplated by this Agreement are subject to the fulfillment, at or before the
Closing, as applicable, of each of the following conditions (all or any of which may be waived in
whole or in part by Duramed, but only in writing, in its sole discretion):

          (a) Representations and Warranties. The representations and warranties made by Shire in this
Agreement shall be true and correct in all material respects on and as of the Closing Date as
though made on and as of the Closing Date or, in the case of representations and warranties made as
of a specified date earlier than the Closing Date, on and as of such earlier date.

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          (b) Performance. Shire shall have performed and complied with, in all material respects, the
agreements, covenants and obligations required by this Agreement to be so performed or complied
with by Shire at or before the Closing.

          (c) Orders and Laws. There shall not be in effect on the Closing Date any judgment, order,
decree, ruling or charge restraining, enjoining or otherwise prohibiting or making illegal the
consummation of any of the transactions contemplated by this Agreement. No court or other
Governmental Authority shall have determined any applicable law to make illegal the consummation of
the transactions contemplated hereby, and no proceeding with respect to the application of any such
applicable law to such effect shall be pending.

          (d) HSR. The applicable waiting period under the HSR Act, if any, shall have been terminated
or expired.

          (e) Effective Date. The Settlement Agreement shall have become effective in accordance with
its terms.

          (f) Deliveries. Shire shall have executed and delivered the item described in Section 2.7(d).

          (g) FDA Letter. The FDA Letter shall have been executed by Duramed and Shire in preparation
for filing.

          (h) Product Material Adverse Effect. There shall not have occurred, or be continuing, a
Product Material Adverse Effect.

          (i) Other Agreements. Duramed and Shire or its Affiliate shall have executed and delivered
the other Transaction Agreements.

     5.2 Conditions to Obligations of Shire. The obligations of Shire hereunder to consummate the
transactions contemplated by this Agreement are subject to the fulfillment, at or before the
Closing, as applicable, of each of the following conditions (all or any of which may be waived in
whole or in part by Shire, but only in writing, in its sole discretion):

          (a) Representations and Warranties. The representations and warranties made by Duramed in
this Agreement shall be true and correct in all material respects on and as of the Closing Date as
though made on and as of the Closing Date or, in the case of representations and warranties made as
of a specified date earlier than the Closing Date, on and as of such earlier date.

          (b) Performance. Duramed shall have performed and complied with, in all material respects,
the agreements, covenants, and obligations required by this Agreement to be so performed or
complied with by Duramed at or before the Closing.

          (c) Orders and Laws. There shall not be in effect on the Closing Date any judgment, order,
decree, ruling or charge restraining, enjoining, or otherwise prohibiting or making illegal the
consummation of any of the transactions contemplated by this Agreement. No court or other
Governmental Authority shall have determined any applicable law to make illegal

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           the consummation of the transactions contemplated hereby or by the other Transaction
Agreements, and no proceeding with respect to the application of any such applicable law to such
effect shall be pending.

          (d) HSR. The applicable waiting period under the HSR Act, if any, shall have been terminated
or expired.

          (e) Effective Date. The Settlement Agreement shall have become effective in accordance with
its terms.

          (f) Deliveries. Duramed shall have executed and delivered to Shire the items described in
Section 2.7(b) and 2.7(d).

          (g) FDA Letter. The FDA Letter shall have been executed by Shire and Duramed in preparation
for filing.

          (h) Other Agreements. Duramed and Shire or its Affiliate shall have executed and delivered
the other Transaction Agreements.

ARTICLE 6

COVENANTS

     6.1 HSR Filing.

          (a) To the extent necessary, each of Duramed and Shire shall simultaneously with the filing of
the Settlement Agreement with the Federal Trade Commission and the Antitrust Division of the U.S.
Department of Justice, file with the Federal Trade Commission and the Antitrust Division of the
U.S. Department of Justice any notification and report form required of it in the reasonable
opinion of both Parties under the HSR Act with respect to the transactions contemplated hereby.
The Parties shall cooperate with one another to the extent necessary in the preparation of any
notification and report form required to be filed under the HSR Act and in the response to any
request for information, including any Second Request for information issued under the HSR Act.
Each Party shall be responsible for its own costs and expenses associated with any filing under the
HSR Act; provided, however, that Duramed shall be responsible for all filing fees required by the
HSR Act.

          (b) Duramed and Shire will cooperate and use all reasonable efforts to make all other
registrations, filings and applications, to give all notices and to obtain as soon as practicable
all governmental and other consents, transfers, approvals, orders, qualifications, authorizations,
permits and waivers, if any, and to do all other things, necessary or desirable for the
consummation of the transactions contemplated hereby.

          (c) Duramed shall be [*] of this Agreement, or [*] of the HSR waiting period by the FTC and/or
DOJ, including [*] Section 7A(e) of the Clayton Act and 16 C.F.R. Section 803.20 .

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     6.2 Conduct of the Business Until Closing. Except for the actions taken or omitted to be
taken pursuant to the prior written consent of Duramed, which consent shall not be unreasonably
withheld or delayed, from the date of this Agreement until the Closing, Shire shall:

          (a) carry on the Adderall Business in, and only in, the ordinary course, in substantially the
same manner as heretofore conducted;

          (b) perform in all material respects all of its obligations under any agreements and
instruments relating to or affecting the Purchased Assets, and comply in all material respects with
all laws applicable to it, the Purchased Assets or the Adderall Business;

          (c) not enter into or assume any material agreement, contract or instrument relating to the
Purchased Assets, or enter into or permit any material amendment, supplement, waiver or other
modification in respect thereof; and

          (d) not make any material change in the selling, distribution, pricing, advertising or
collection practices for the Product, including any special effort or program to sell, consign or
solicit order for the Product to customers or to discount, factor or collect sooner than normal any
accounts receivable.

     6.3 Post-Closing Orders and Payments. From and after the Closing Date, Shire shall (i) not
accept any purchase orders on behalf of Duramed, (ii) promptly deliver to Duramed any purchase
orders for Product received after the Closing and any payments received from third parties for
Product purchased from Duramed after the Closing, and (iii) refer all inquiries it shall receive
with respect to the Product, to Duramed or its designee. Likewise, Duramed shall promptly deliver
to Shire any payments Duramed receives from third parties for Product purchased from Shire prior to
the Closing.

     6.4 Right to Investigate. After the date hereof up to the Closing, Shire shall afford to
representatives of Duramed reasonable access to offices, plants, properties, books and records of
Shire relating to the Product and the Purchased Assets, during normal business hours, in order that
Duramed may have an opportunity to make such reasonable investigations as it desires with respect
to the Product.

     6.5 Retention of Records. Shire will, and will cause each of its Affiliates to, retain all
books and records relating to the Adderall Business and the Purchased Assets in the United States
in accordance with Shire’s record retention policies as presently in effect or as otherwise
required by law.

     6.6 Non-Solicitation.

          (a) During the period commencing upon the signing of this Agreement and ending upon the first
anniversary of the Closing Date, Duramed (which for purposes of this Section 6.6 includes its
Affiliates) shall not, either directly or indirectly, solicit, recruit, induce, encourage or
attempt to solicit, recruit, induce or encourage any employee of Shire or its Affiliates who work,
or at any time within [*] prior to the Closing Date, worked, on matters involving the Product to
terminate his or her employment relationship with Shire or its Affiliates and become employed by
Duramed or become employed by an independent contractor for

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           Duramed, whether or not such employee is a full-time employee and whether or not such
employment relationship is pursuant to a written agreement or is at-will. Nothing in this Section
6.6(a) shall apply if the employee is hired in response to a public advertisement or general
solicitation disseminated by either Party.

          (b) Prior to the Closing Date, neither Shire nor any of its Affiliates or any Person acting on
their behalf shall (i) solicit or encourage any inquiries or proposals for, or enter into any
discussions with respect to, the acquisition of any properties and assets held for use in
connection with, necessary for the conduct of, or otherwise material to, the Adderall Business (an
“Acquisition Transaction”) or (ii) furnish or cause to be furnished any non-public information
concerning the Adderall Business to any Person (other than Duramed), for purposes of facilitating
an Acquisition Transaction. Shire shall promptly notify Duramed of any inquiry or proposal
received by Shire with respect to any such Acquisition Transaction. Shire shall not sell, transfer
or otherwise dispose of, grant any option or proxy to any Person with respect to, create any Lien
upon, or transfer any interest in, any Purchased Asset, other than in the ordinary course of
business and consistent with this Agreement.

     6.7 Managed Markets.

          (a) On the Closing Date and to the extent permitted by applicable law, Duramed shall become
responsible for the marketing and promotion of Duramed Labeled Product across all managed market
and government segments in the Territory and with respect thereto, shall have exclusive
responsibility for: (i) contract execution, (ii) government reporting, rebate and chargeback
processing and payment, federal supply schedule calculations and pricing schedules, (iii) contract
compliance, monitoring and audits, and (iv) contract administration and claims processing
(collectively, the “Managed Market Activities”). Without limiting the generality of the foregoing,
with respect to rebates under Medicaid and federal supply service contracts, Duramed shall assume
following the Closing Date responsibility therefor under its own Medicaid and federal supply
service contracts. On or prior to the Closing Date Duramed shall have obtained its own NDC number
for the Product and shall ensure that all sales of Product by Duramed can be accomplished under the
NDC number of Duramed. Duramed shall use its new NDC numbers on all invoices, orders and other
communications with customers and Regulatory Authorities or other governmental entities. Following
the Closing Date, Duramed shall be responsible for the processing, payment, administration and
support of (x) all chargebacks under any government, managed market or other contract
(“Chargebacks”) and (y) all rebates due pursuant to any United States government (federal
or state) rebate program under any government, managed market or other contract (“Rebates”) for
Duramed Labeled Product. Shire shall be responsible for the processing, payment, administration
and support of all Chargebacks and Rebates for Shire Labeled Product.

          (b) Shire shall provide Duramed with all information relating to the Product and the prices
thereof that Duramed reasonably requires in order to comply with applicable rules and regulations
relating to Medicaid Rebates. When requested, such information shall be provided by Shire to
Duramed promptly, and in any event, within [*] after Duramed’s written request therefor. Promptly
after the Closing Date, Shire shall provide Duramed with the baseline Average Manufacturers Price
(“AMP”) for the Product. Within [*] after the end of the [*] after

- 19 -

 

           the Closing Date, Duramed shall calculate a unit (tablet/capsule) AMP and “Best Price” for the
Product and provide such calculations in writing to Shire.

          (c) Shire shall provide to Duramed within [*] after request therefor all information
reasonably requested by Duramed to enable Duramed to calculate the price to be paid for each
Product by a “covered entity” under the Public Health Service Act, as defined in 42 U.S.C. §
256b(a)(4).

          (d) Shire shall use reasonable best efforts to terminate all Contracts providing for the
payment of commercial Rebates with respect to the Product (“Rebate Contracts”) as of the [*]
following the Closing. Shire shall not assign to Duramed, and Duramed shall not assume from Shire,
any of the Rebate Contracts. Shire shall continue processing Rebates owed under the Rebate
Contracts with respect to Product dispensed prior to the termination of such Rebate Contracts.
Upon Closing, Shire shall issue a letter to commercial Rebate customers advising such customers of
Shire’s responsibilities in connection with Rebate Contracts and associated Rebates.

          (e) Shire shall use reasonable best efforts to terminate all Contracts providing for payment
of Chargebacks to government and commercial customers with respect to Product (“Chargeback
Contracts”) upon Closing. Shire shall not assign to Duramed, and Duramed shall not assume from
Shire, any of the Chargeback Contracts. Upon Closing, Shire shall issue a letter to the trade
(wholesalers and distributors) and to commercial Chargeback customers advising such customers of
Shire’s responsibilities in connection with Chargeback Contracts and associated Chargebacks and
administrative fees.

     6.8 Returns. From and after the Closing Date (a) Shire shall be solely responsible, at its
own cost and expense, for the processing, payment, administration and support of all returns of
Shire Labeled Product, regardless of when the return is made, and (b) Duramed shall be solely
responsible, at its own cost and expense, for the processing, payment, administration and support
of all returns of Duramed Labeled Product. If any quantities of Duramed Labeled Products are
returned to Shire, Shire shall notify Duramed as soon as practicable and ship them to the facility
designated by Duramed at Duramed’s cost. Shire, at its option, may advise the customer who made
the return that Duramed Labeled Products should have been returned to Duramed. At Duramed’s
request, Shire shall destroy the Duramed Labeled Products and Duramed shall reimburse Shire for
such cost of destruction. If any quantities of Shire Labeled Products are returned to Duramed,
Duramed shall notify Shire as soon as practicable and ship them to the facility designated by Shire
at Shire’ cost. At Shire’s request, Duramed shall destroy Shire Labeled Products and Shire shall
reimburse Duramed for such cost of destruction.

     6.9 Certain Sales. Duramed shall not sell any Product following the Closing Date under
Shire’s NDC Number or any Shire labeling or packaging material for the Product. Shire shall not
sell any Product following the Closing except pursuant to the Supply Agreement.

ARTICLE 7

INDEMNIFICATION

     7.1 Indemnification by Shire. From and after the Closing, Shire shall reimburse and indemnify
Duramed, Duramed’s Affiliates, and their respective officers, directors, employees,

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and agents in respect of, and hold each of them harmless from and against, any and all Losses
suffered, incurred, or sustained by any of them or to which any of them becomes subject, resulting
from, arising out of, or relating to:

          (a) the Retained Liabilities or the Excluded Assets;

          (b) any misrepresentation or breach of representation or warranty by Shire made or contained
in this Agreement;

          (c) any failure of Shire to materially perform or observe any covenant or agreement to be
performed or observed by Shire pursuant to this Agreement;

          (d) any action or inaction of Shire with respect to the Purchased Assets prior to the Closing
Date, except for Losses arising as a result of Liabilities expressly included in the Assumed
Liabilities; and

          (e) any product liability claim with respect to the Shire Labeled Product sold prior to the
Closing.

     7.2 Indemnification by Duramed. From and after the Closing, Duramed shall reimburse and
indemnify Shire, Shire’s Affiliates and their respective officers, directors, employees, and agents
in respect of, and hold each of them harmless from and against, any and all Losses suffered,
incurred, or sustained by any of them or to which any of them becomes subject, resulting from,
arising out of, or relating to:

          (a) the Assumed Liabilities;

          (b) any misrepresentation or breach of representation or warranty by Duramed made or contained
in this Agreement;

          (c) any failure by Duramed to materially perform or observe any covenant or agreement to be
performed or observed by Duramed pursuant to this Agreement; and

          (d) any action or inaction of Duramed with respect to the Purchased Assets after the Closing
Date.

     7.3 Limitation of Liability.

          (a) Notwithstanding anything to the contrary contained in this Agreement, no amounts of
indemnity shall be payable as a result of any claim in respect of a Loss arising under Section 7.1
unless and until the indemnified parties thereunder have suffered, incurred, sustained, or become
subject to Losses referred to in such Sections in excess of [*] in the aggregate (in which event
the indemnifying Party shall be liable for the entire amount of such Losses).

          (b) The maximum aggregate liability of Shire under this Article 7 shall not exceed [*],
provided, however, that Losses related to or arising out of any Third Party Claim shall not be
subject to any such limitation.

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          (c) Notwithstanding anything to the contrary contained in this Agreement, no amounts of
indemnity shall be payable as a result of any claim in respect of a Loss arising under Sections 7.1
or 7.2:

               (i) with respect to any Loss, to the extent that the Party seeking indemnification had a
reasonable opportunity, but failed, in good faith to mitigate the Loss; or

               (ii) with respect to any Loss, to the extent that such Loss is caused by (A) any
misrepresentation or breach of warranty, covenant or agreement by the Party seeking indemnification
in the Agreement or (B) the gross negligence or intentional misconduct of such Party or its
Affiliates or any of their respective officers, directors, employees, or agents.

          (d) No Party hereto shall be entitled to any indemnification under Section 7.1(b) or Section
7.2(b), as applicable, if (i) the other Party shall have notified such Party in writing on or prior
to the Closing Date, or disclosed to such Party in the Shire Disclosure Schedule or the Duramed
Disclosure Schedule, as applicable and as may be supplemented or amended prior to the Closing Date,
of the breach of, or inaccuracy in, such representation or warranty and (ii) such Party has
permitted the Closing to occur.

     7.4 No Consequential Damages. IN NO EVENT SHALL ANY PARTY BE LIABLE TO ANY OTHER PARTY FOR
INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF OR IN
CONNECTION WITH THIS AGREEMENT, EXCEPT TO THE EXTENT THAT SUCH DAMAGES ARISE FROM THIRD PARTY
CLAIMS SUBJECT TO INDEMNIFICATION UNDER ARTICLE 7.

     7.5 Procedures for Indemnification for Third Party Claims.

          (a) In the case of a third party claim or demand (“Third Party Claim”) made by any Person who
is not a Party to this Agreement (or an Affiliate thereof) as to which a Party (the “Indemnitor”)
may be obligated to provide indemnification pursuant to this Agreement, such Party seeking
indemnification hereunder (“Indemnitee”) will notify the Indemnitor in writing of the Third Party
Claim (and specifying in reasonable detail the factual basis for the Third Party Claim and to the
extent known, the amount of the Third Party Claim) reasonably promptly after becoming aware of such
Third Party Claim; provided, however, that failure to give such notification will not affect the
indemnification provided hereunder except to the extent the Indemnitor shall have been actually
prejudiced as a result of such failure.

          (b) If a Third Party Claim is made against an Indemnitee, the Indemnitor will be entitled,
within [*] after receipt of written notice from the Indemnitee of the commencement or assertion of
any such Third Party Claim, to assume the defense thereof (at the expense of the Indemnitor) with
counsel selected by the Indemnitor and reasonably satisfactory to the Indemnitee, for so long as
the Indemnitor is conducting a good faith and diligent defense. Should the Indemnitor so elect to
assume the defense of a Third Party Claim:

               (i) the Indemnitor will not be liable to the Indemnitee for any legal or other expenses
subsequently incurred by the Indemnitee in connection with the defense thereof; provided, however,
that if under applicable standards of professional conduct a conflict of

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interest exists between the Indemnitor and the Indemnitee in respect of such claim, such
Indemnitee shall have the right to employ separate counsel (which shall be reasonably satisfactory
to the Indemnitor) to represent such Indemnitee with respect to the matters as to which a conflict
of interest exists and in that event the reasonable fees and expenses of such separate counsel
shall be paid by such Indemnitor; and provided further, that the Indemnitor shall only be
responsible for the reasonable fees and expenses of one separate counsel for such Indemnitee;

               (ii) so long as the Indemnitor is conducting the defense of the Third Party Claim in
accordance with Section 7.1 or 7.2, as the case may be, the Indemnitee may retain separate
co-counsel at its sole cost and expense and participate if reasonably practicable in the defense of
the Third Party Claim;

               (iii) the Indemnitor will promptly supply to the Indemnitee copies of all material
correspondence and documents relating to or in connection with such Third Party Claim and keep the
Indemnitee informed of developments relating to or in connection with such Third Party Claim, as
may be reasonably requested by the Indemnitee (including providing to the Indemnitee on reasonable
request updates and summaries as to the status thereof); and

               (iv) all Indemnitees shall reasonably cooperate with the Indemnitor in the defense thereof
(such cooperation to be at the expense, including reasonable legal fees and expenses, of the
Indemnitor).

          (c) If the Indemnitor does not elect to assume control of the defense of any Third Party Claim
within the [*] period set forth above, or if such good faith and diligent defense is not being or
ceases to be conducted by the Indemnitor, the Indemnitee shall have the right, at the expense of
the Indemnitor, after [*] notice to the Indemnitor of its intent to do so, to undertake the defense
of the Third Party Claim for the account of the Indemnitor (with counsel selected by the
Indemnitee), and to compromise or settle such Third Party Claim, exercising reasonable business
judgment.

          (d) If the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee for a
Third Party Claim, the Indemnitee will agree to any settlement, compromise, or discharge of such
Third Party Claim that the Indemnitor may recommend that by its terms obligates the Indemnitor to
pay the full amount of Losses (whether through settlement or otherwise) in connection with such
Third Party Claim and unconditionally and irrevocably releases the Indemnitee completely from all
Liability in connection with such Third Party Claim; provided, however, that, without the
Indemnitee’s prior written consent, the Indemnitor shall not consent to any settlement, compromise,
or discharge (including the consent to entry of any judgment), and the Indemnitee may refuse to
agree to any such settlement, compromise, or discharge, that provides for injunctive or other
nonmonetary relief affecting the Indemnitee. If the Indemnitor acknowledges in writing its
obligation to indemnify the Indemnitee for a Third Party Claim, the Indemnitee shall not (unless
required by law) admit any liability with respect to, or settle, compromise or discharge, such
Third Party Claim without the Indemnitor’s prior written consent (which consent shall not be
unreasonably withheld or delayed).

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     7.6 Losses That Are Not Third Party Claims. Any claim on account of Losses which does not
involve a Third Party Claim shall be asserted by reasonably prompt written notice (stating in
reasonable detail, the basis of such claim and a reasonable estimate of the amount thereof) given
by the Indemnitee to the Indemnitor. For a period of [*] from and after receipt of the written
notice, the Parties shall attempt in good faith to resolve such claim for indemnification. If the
Parties are unable to resolve such claim, the Indemnitee may thereafter pursue any and all remedies
at its disposal to enforce said indemnification claim.

     7.7 Termination of Indemnification Obligations. The obligations of each Party to indemnify,
defend and hold harmless the other Party and other Indemnitees (a) pursuant to Sections 7.1(b) and
7.2(b) shall terminate when the applicable Survival Period expires pursuant to Section 4.4, and (b)
pursuant to Sections 7.1(a), (c), (d) and (e), and Sections 7.2(a), (c) and (d) shall survive until
the earlier of the expiration of the applicable statute of limitations, if any, and the sixth (6th)
anniversary of the Closing Date; provided, however, that such obligations to indemnify, defend, and
hold harmless shall not terminate with respect to any individual item as to which the Indemnitee
shall have before the expiration of the Survival Period, made a claim by delivering a written
notice (stating in reasonable detail the basis of such claim and a reasonable estimate of the
amount thereof) to the Indemnitor.

     7.8 Other Matters. In the event of payment in full by an Indemnitor to any Indemnitee in
connection with any Third Party Claim, such Indemnitor will 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 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 will cooperate with
such Indemnitor in a reasonable manner, and at the cost and expense of such Indemnitor, in
prosecuting any subrogated right or claim.

     7.9 Other Limitations.

          (a) For the avoidance of doubt and without limitation to the provisions of Articles 4 and 5,
an Indemnitor shall have no obligation to indemnify, defend and hold harmless an Indemnitee from
and against any portion of Losses under Section 7.1 or Section 7.2 to the extent that such portion
of such Losses results directly from any action taken by, or at the express written request of,
such Indemnitee. Neither Party nor any of its respective Affiliates shall have or be subject to
any liability to the other Party, its Affiliates or any other Person resulting from the
distribution to, or use of any information, documents or materials made available to it by the
other Party, including any information, documents or materials in any data rooms, management
presentations or other form in expectation of the transactions contemplated hereby.

          (b) No liability shall arise in respect of any breach of any representation, warranty,
covenant or agreement herein to the extent that liability for such breach occurs (or is increased)
directly as a result of any retrospective application of a change in applicable law, or in
accounting policies, procedures or practices, announced by a Governmental Authority or, if not
announced in advance of taking effect, taking effect, after the Closing Date, unless Shire or
Duramed, as the case may be, knew of any such retrospective application of a change in applicable
law, or in such accounting policies, procedures or practices at the time of Closing.

- 24 -

 

          (c) No Party shall be entitled to recover any Losses or other amounts due from the other Party
pursuant to this Agreement by retaining or setting off amounts (whether or not such amounts are
liquidated or reduced to judgment) against any amounts due or to become due from such first Party
to such second Party hereunder or under any Transaction Agreement or under any document or
instrument delivered pursuant hereto or thereto or in connection herewith or therewith. For the
avoidance of doubt, the foregoing is without prejudice to any right of set-off expressly provided
for in any Transaction Agreement, which does not involve setting off amounts due under this
Agreement.

          (d) All amounts paid by Shire or Duramed under this Article 7 shall be treated for all
purposes as adjustments to the Purchase Price except to the extent such treatment is not permitted
by applicable law. In the event that treatment as an adjustment to the Purchase Price is disputed
by any taxing authority, the Party receiving notice of such dispute shall promptly notify and
consult with the other Party concerning resolution of such dispute.

     7.10 Exclusive Remedy. Other than in the case of fraud, the indemnification provided to any
Person pursuant to this Article 7 shall be such Person’s sole remedy for any claims arising
hereunder, or otherwise in connection with or arising out of the transactions described herein,
including any breach by any Party hereto of any representation, warranty, or covenant contained in
this Agreement, or in any certificate or document (to the extent such certificate or documents
relate to matters covered by the representation, warranties, or covenants contained herein)
required to be delivered in connection herewith, provided that nothing herein shall limit the
rights of either Party to seek and obtain injunctive relief to specifically enforce the other
Party’s obligations.

     7.11 Net Losses and Subrogation.

          (a) Notwithstanding anything contained herein to the contrary, the amount of any Losses
incurred or suffered by an Indemnitee shall be calculated after giving effect to: (i) any insurance
proceeds received by the Indemnitee (or any of its Affiliates) with respect to such Losses; (ii)
any Tax benefit realized by the Indemnitee (or any of its Affiliates) arising from the facts or
circumstances giving rise to such Losses; and (iii) any recoveries obtained by the Indemnitee (or
any of its Affiliates) from any other third party. Each Indemnitee shall exercise its reasonable
efforts to obtain such proceeds, benefits and recoveries, provided that the Indemnitee shall not be
obligated to make such an insurance claim if the Indemnitee in its reasonable judgment believes
that the cost of pursuing such an insurance claim together with any corresponding increase in
insurance premiums or other chargebacks to the Indemnitee, as the case may be, would exceed the
value of the claim for which the Indemnitee is seeking indemnification. If any such proceeds,
benefits or recoveries are received by an Indemnitee (or any of its Affiliates) with respect to any
Losses after the Indemnitee (or any Affiliate) has received the benefit of any indemnification
hereunder with respect thereto, the Indemnitee (or such Affiliate) shall pay to the Indemnitor the
amount of such proceeds, benefits or recoveries (up to the amount of the Indemnitor’s payment).

          (b) Upon making any payment to an Indemnitee in respect of any Losses, the Indemnitor will, to
the extent of such payment, be subrogated to all rights of the Indemnitee (and its Affiliates)
against any third party in respect of the Losses to which such payment relates. Such

- 25 -

 

           Indemnitee (and its Affiliates) and Indemnitor will execute upon request all instruments
reasonably necessary to evidence or further perfect such subrogation rights.

ARTICLE 8

TERMINATION

     8.1 Termination Prior to Closing. This Agreement may be terminated at any time prior to
Closing:

          (a) by mutual written consent of Duramed and Shire;

          (b) by Duramed or Shire in the event that any competent Governmental Authority indicates its
intention to initiate a judicial or administrative action to obtain an order, decree or ruling to
restrain, enjoin, or otherwise prohibit the transactions contemplated by this Agreement, and such
order, decree, ruling, or other action shall have become final and non-appealable; or

          (c) by a Party in the event that the other Party (the “Defaulting Party”) shall have breached,
or failed to comply with, any of such Defaulting Party’s obligations under this Agreement, or any
representation or warranty made by the Defaulting Party shall have been incorrect in any material
respects when made; or

          (d) by either Duramed or Shire if the Closing is not consummated pursuant to the terms of this
Agreement prior to December 31, 2006, provided that the right to terminate the Agreement under this
Section 8.1 (c) shall not be available to a Party hereto if such Party has failed to perform in all
material respects its obligation under this Agreement and such failure has been the cause of, or
results in, the failure of the Closing to occur on or before such date.

     8.2 Effect of Termination Prior to Closing. In the event of termination of this Agreement as
provided in Section 8.1, this Agreement shall forthwith become void and there shall be no liability
on the part of either Party hereto except (a) as set forth in Section 11.1, and (b) nothing herein
shall relieve either Party from Liability for any breach of this Agreement prior to such
termination.

ARTICLE 9

PATENT PROSECUTION, MAINTENANCE AND ENFORCEMENT

     9.1 Discretionary Duty to Maintain. Shire may, at its sole discretion and cost, maintain the
Licensed Patents.

     9.2 Abandonment of Maintenance by Shire. Shire shall notify Duramed in the event it decides
at any time to discontinue the maintenance of any Licensed Patent. Such notification shall be
given at least [*] prior to the date on which such patent will become abandoned. Duramed shall
then have the option, exercisable upon written notification to Shire, to assume full
responsibility, at its discretion and sole cost, for prosecution of the affected maintenance of
such patent. In the event Duramed exercises such option, such Licensed Patent shall be assigned to
Duramed. Shire shall provide all assistance reasonably necessary to assign to the Duramed all
rights, interests and titles of such Licensed Patent.

- 26 -

 

     9.3 Patent Marking. Duramed and its sublicensees and Affiliates shall mark all Products made
under this Agreement with a notice in accordance with 35 U.S.C. §287.

     9.4 Suits for Infringement of the Licensed Patents. If Shire or Duramed becomes aware of
infringement of any patent included in the Licensed Patents by a third party, such Party shall
promptly notify the other Party in writing to that effect. If, prior to the expiration of [*] from
said notice, Shire has not obtained a discontinuance of such infringement or brought suit in such
country against the third party infringer and such infringement is relevant in a material respect
to a Product or the Purchased Assets, then Duramed shall have the right to bring suit in such
country against such infringer and join Shire as a party. The foregoing shall not preclude the
Parties from jointly seeking such discontinuance or bringing suit and, in any event, each Party
will cooperate with the other in any suit and will have the right to consult with the other and be
represented by its own counsel at its own expense. Prior to disposition of any moneys recovered,
the expenses of the Parties in bringing suit shall be reimbursed out of the moneys recovered, with
the Party bringing the suit being reimbursed first, then fifty percent (50%) of the remainder, if
any, of moneys recovered by either Party upon final judgment or settlement of any infringement suit
shall be retained by the Party bringing the suit, and fifty percent (50%) shall be paid to the
other Party; provided, however, that (a) if Shire has not obtained a discontinuance of such
infringement or brought suit against the third party infringer and Duramed determines to bring such
suit, Duramed shall be entitled to one hundred percent (100%) of such remainder, and (b) in no
event shall any Party who has not voluntarily joined in the relevant action be entitled to recovery
of any damages hereunder. No settlement by a Party bringing a suit shall diminish the rights or
interests of the other Party without the other Party’s written consent.

ARTICLE 10

DISPUTE RESOLUTION

     10.1 Disputes. The Parties hereby agree that all disputes arising under this Agreement shall
be referred to a senior executive of Duramed and a senior executive of Shire (the
“Representatives”). If any such matter has not been resolved within [*] of such referral to the
Representatives either Party may invoke the provisions of Section 10.2 for such dispute. No
dispute resolution procedure set forth in this Agreement shall be construed as an agreement to
arbitrate under any federal or state arbitration Law, including the Federal Arbitration Act, and
shall not deprive a court of competent jurisdiction from resolving any dispute arising under, or
related to, this Agreement.

     10.2 Litigation. Any dispute that is not resolved as provided in the preceding Section 10.1,
whether before or after termination of this Agreement, may be submitted by either Party only to any
court of competent jurisdiction. This Agreement shall be governed by, and construed in accordance
with, the Laws of the State of New York. The Parties unconditionally and irrevocably agree and
consent to the exclusive jurisdiction of the courts located in New York, NY and waive any objection
with respect thereto, for the purpose of any action, suit or proceeding arising out of or relating
to this Agreement or the transactions contemplated hereby and further agree not to commence any
such action, suit or proceeding except in any such court.

     10.3 Injunctive Relief. Notwithstanding anything to the contrary in this Agreement, either
Party shall have the right to seek temporary injunctive relief in any court of competent

- 27 -

 

jurisdiction as may be available to such Party under the Laws and rules applicable in such
jurisdiction with respect to any matters arising out of the other Party’s performance of its
obligations under this Agreement.

ARTICLE 11

GENERAL PROVISIONS

     11.1 Payment of Transaction Expenses. All legal fees and other expenses incurred on behalf of
Shire in connection with the negotiation of this Agreement and the consummation of the transactions
contemplated herein will be borne by Shire, whether or not the Closing shall have occurred. All
legal fees and other expenses incurred on behalf of Duramed in connection with the negotiation of
this Agreement and the consummation of the transactions contemplated herein will be borne by
Duramed, whether or not the Closing shall have occurred.

     11.2 Access to Information Post-Closing. After the Closing, Duramed agrees to cooperate with
Shire and to grant to Shire and its employees, attorneys, accountants, officers, representatives,
and agents, during normal business hours and upon at least [*] advance notice, reasonable access to
Duramed’s management personnel and to the records relating to the Product (including the Product
Registrations) and to permit copying at Shire’s expense or, where reasonably necessary, to loan
original documents relating to the Purchased Assets during the period the Purchased Assets were
owned by Shire for the sole purposes of (a) any financial reporting or tax matters (including any
financial and tax audits, tax contests, tax examination, preparation of any Shire’s tax returns or
financial records) relating to the Product, (b) any claims or litigation involving Shire and the
Purchased Assets relating to the Product, (c) any investigation of Shire being conducted by any
federal, state, or local governmental authority relating to the Product, (d) any matter relating to
any indemnification or representation or warranty or any other term of this Agreement, or (e) any
similar or related matter. Duramed shall maintain, to the extent required by applicable law, but
in any event for not less than six (6) years, all such records and documents in the United States
of America and shall not destroy or dispose of any such records and documents prior to the end of
such required or six (6) year period without the prior written consent of Shire.

     11.3 Notices. All notices or other communications that are required or permitted under this
Agreement shall be in writing and delivered personally, sent by facsimile (and promptly confirmed
by personal delivery or overnight courier as provided in this Agreement), or sent by
internationally-recognized overnight courier to the addresses below. Any such communication shall
be deemed to have been given (a) when delivered, if personally delivered or sent by facsimile on a
Business Day (so long as promptly confirmed by personal delivery or overnight courier as provided
in this Agreement), and (b) on the second Business Day after dispatch, if sent by
internationally-recognized overnight courier. Unless otherwise specified in writing, the mailing
addresses of the Parties shall be as described below.

	 	 	 
	For Duramed:

	 	Duramed Pharmaceuticals, Inc.
	 

	 	400 Chestnut Ridge Road
	 

	 	Woodcliff Lake, NJ 07677
	 

	 	Phone: 201-930-3300
	 

	 	Fax: 201-930-3330

Attention: President

- 28 -

 

	 	 	 
	with a copy to:

	 	Barr Pharmaceuticals, Inc.
	 

	 	400 Chestnut Ridge Road
	 

	 	Woodcliff Lake, NJ 07677
	 

	 	Phone: 201-930-3300
	 

	 	Fax: 888-843-0563
	 

	 	Attention: General Counsel
	 
	 	 
	For Shire:

	 	Shire LLC
	 

	 	725 Chesterbrook Boulevard
	 

	 	Wayne, Pennsylvania 19087-5637
	 

	 	Fax: (484) 595-8163
	 

	 	Attention: General Counsel
	 
	 	 
	with a copy to:

	 	Morgan, Lewis & Bockius LLP
	 

	 	502 Carnegie Center
	 

	 	Princeton, NJ 08540
	 

	 	Fax: (609) 919-6701
	 

	 	Attention: Randall B. Sunberg

     11.4 Entire Agreement; Amendment. This Agreement, the Pharmacovigilance Agreement, the
Trademark License Agreement and the Supply Agreement, including the exhibits and schedules attached
hereto and thereto (each of which is herby and thereby incorporated herin and therein by reference)
(collectively, the “Transaction Agreements”), sets forth the complete, final and exclusive
agreement and all the covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto and supersedes and terminates all prior agreements and
understandings between the Parties, which shall continue to govern the obligations of the Parties
with respect to information disclosed thereunder with respect to periods prior to the Effective
Date. There are no covenants, promises, agreements, warranties, representations, conditions or
understandings, either oral or written, between the Parties other than as are set forth herein. No
subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the
Parties unless reduced to writing and signed by an authorized officer of each Party. For the
avoidance of doubt, the Parties agree that all covenants, promises, agreements, warranties,
representations, conditions, and understandings set forth herein are made and deemed effective as
of the Effective Date, and that the execution of this Agreement shall not constitute a waiver of
any right or claim of either Party as of the Effective Date.

     11.5 Assignment. Neither this Agreement nor any of the rights or obligations of the Parties
hereunder may be assigned by either Party without the prior written consent of the other Party;
provided, however, that (a) Shire or Duramed may assign this Agreement to an Affiliate, and (b)
following the Closing, either Party shall be entitled, without the prior written consent of the
other, to assign its rights and obligations hereunder in connection with a merger or similar
reorganization or the sale or all or substantially all of its assets. Any attempted assignment or
delegation in contravention hereof shall be null and void. Subject to the foregoing, this

- 29 -

 

Agreement and all rights and powers granted and obligations created hereby will bind and inure
to the benefit of the Parties and their respective successors and assigns.

     11.6 Headings. The headings for each article and section in this Agreement have been inserted
for convenience of reference only and are not intended to limit or expand on the meaning of the
language contained in the particular article or section.

     11.7 Independent Parties. In making and performing this Agreement, Shire and Duramed shall
act at all times as independent contractors and nothing contained in this Agreement shall be
construed or implied for any purpose to create an agency, partnership, limited partnership, joint
venture or employer and employee relationship between Shire and Duramed and this Agreement shall
not be construed to suggest otherwise. At no time shall one Party make commitments or incur any
charges or expenses for or in the name of the other Party.

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

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

     11.10 Counterparts. This Agreement may be executed in counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same instrument.
Signatures provided by facsimile transmission shall be deemed to be original signatures.

     11.11 No Third Party Beneficiaries. No Person other than Shire and Duramed and permitted
assignees hereunder shall be deemed an intended beneficiary hereunder or have any right to enforce
any term of this Agreement.

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

     11.13 No Strict Construction. This Agreement has been prepared jointly and shall not be
strictly construed against either Party.

     11.14 Public Disclosure. No announcement or other disclosure, public or otherwise, concerning
the financial or other terms of this Agreement shall be made, either directly or indirectly, by any
Party without first obtaining the written approval of the other Party and agreement upon the nature
and text of such announcement or disclosure, such approval and agreement not to be unreasonably
withheld or delayed. Notwithstanding the foregoing:

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          (a) Each Party agrees that disclosures may need to be made to the Securities and Exchange
Commission (“SEC”) and other Regulatory Authorities and each Party agrees that it shall reasonably
cooperate with the other with respect to all disclosures regarding this Agreement to such
Regulatory Authorities. In addition, the Parties will coordinate in advance with each other in
connection with the redaction of certain provisions of this Agreement with respect to any SEC
filings, and each Party shall use reasonable efforts to seek confidential treatment for such terms;
provided, however, that each Party shall ultimately retain control over what information to
disclose to the SEC or any other such agencies.

          (b) The Parties shall be free to publicly disclose information contained in any materials that
have been previously approved for disclosure by the other Party, without further approvals from the
other Party hereunder, to the extent there have been no material additions or changes thereto.

     11.15 Bulk Sales Laws. The Parties hereby waive compliance with any UCC bulk sales or
comparable statutory provisions of each applicable jurisdiction.

[Remainder of page intentionally left blank]

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     IN WITNESS WHEREOF, the Parties hereto have each caused this Agreement to be duly executed as
of the date first above written

	 	 	 	 	 
	SHIRE LLC  
	 
	 	 	 	 
	By:
	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 
	Name:

	 	Matthew Emmens
	 	 
	Title:

	 	CEO
	 	 
	 
	 	 	 	 
	SHIRE LLC  
	 
	 	 	 	 
	By:
	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 
	Name:
	 	Matthew Emmens	 	 
	Title:
	 	CEO	 	 
	 
	 	 	 	 
	DURAMED PHARMACEUTICALS, INC.
	 
	 	 	 	 
	By:
	 	/s/ Fred Wilkinson	 	 
	 

	 	 	 	 
	Name:

	 	Fred Wilkinson	 	 
	Title:

	 	President & C.O.O.
	 	 

[Signature Page to Product Acquisition and License Agreement]

 

 

EXHIBIT A

ADDERALL® IR PHARMACOVIGILANCE AGREEMENT

DATE: As of August 14, 2006

PARTIES:

	(1)	 	SHIRE DEVELOPMENT, INC., having its place of business at 725 Chesterbrook Boulevard, Wayne,
PA 19087-5637 (“Shire”)

	(2)	 	DURAMED PHARMACEUTICALS, INC., having its place of business at 400 Chestnut Ridge Road,
Woodcliff Lake, NJ 07677 (“Duramed”).

RECITALS

	(A)	 	With effect from August 14, 2006, Shire and Duramed entered into a Product Acquisition and
License Agreement (the “Acquisition and License Agreement”) with respect to the promotion of
the Product (as defined below) in the Territory (as defined below).
	 
	(B)	 	Pursuant to the terms of the Acquisition and License Agreement, the Parties are obligated to
enter into this Agreement to provide for the Parties’ respective obligations in relation to
medical information and pharmacovigilance services for the Product.
	 
	(C)	 	In consideration of the above recitals and the mutual promises, covenants and obligations as
set out in this Agreement, and for other good and valuable consideration, the receipt and
sufficiency of which is acknowledged, and intending to be legally bound, the Parties agree as
follows.

OPERATIVE PROVISIONS

	1	 	INTERPRETATION
	 
	1.1	 	In this Agreement:
	 
	 	 	“Acquisition and License Agreement” has the meaning given to it in Recital (A).
	 
	 	 	“Adverse Event” means any untoward medical occurrence in a patient or clinical investigator
subject administered the Product and which does not necessarily have a causal relationship
with this treatment for which the Product is used. An adverse event can therefore be any
unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or
disease temporally associated with the

 

 

	 	 	use of a medicinal (investigational) product, whether or not related to the Product. A
pre-existing condition that worsened in severity after administration of the Product would
be considered an adverse event.

“Awareness Date” or “Clock Date” means the date on which a Party first becomes aware of an
Adverse Event or a Suspected Adverse Drug Reaction and, in relation to a third party
Representative of a Party, such as clinical research organizations or distributors, that
have contractual and/or regulatory obligations to report Adverse Events or a Suspected
Adverse Drug Reaction to that Party, the date on which such third parties first become
aware of that Adverse Event or a Suspected Adverse Drug Reaction. For both Parties this is
considered day zero.

“Business Day” means a day (other than a Saturday or Sunday) on which banks in the United
States are open for business.

“Confidential Information” means all secret, confidential or proprietary information or
data, whether provided in written, oral, graphic, video, computer, electronic or other
form, provided pursuant to this Agreement or generated pursuant to this Agreement.

“Effective Date” has the meaning given to it in the Acquisition and License Agreement.

“Marketing Authorization” means any authorization granted by a Regulatory Authority
required to permit the commercial marketing and sale of the Product in the Territory.

“Medical Information” means information about the Product including, but not limited
to, clinical and technical matters such as therapeutic uses for both the licensed and
unlicensed indications, drug interactions, drug-disease information, Adverse Events,
product stability and other product characteristics.

“Periodic Safety Report” means a safety report generated at set times and in accordance
with FDA guidelines for the purpose of demonstrating the current risk/benefit analysis of
the Product according to present knowledge and produced to provide a historical perspective
on the safety issues surrounding the Product.

“Product” has the meaning given to it in the Acquisition and License Agreement.

“Reference Safety Information” means the recognized Adverse Reactions to the Product
contained in all or any one of Shire’s Developmental Core Safety Information (DCSI) in an
investigator’s brochure, Shire’s Company Core Safety Information (CCSI) in a marketed
product Company Core Data Sheet (CCDS) and Shire’s official local product labeling
(including the local Summary of Product Characteristics (SPC)).

 

 

“Regulatory Approval” means the granting of all necessary regulatory and governmental
approvals by a regulatory or other governmental body required to market and sell the
Product in the Territory.

“Regulatory Authority” means any competent regulatory authority or other governmental body
responsible for granting any Regulatory Approval.

“Representatives” has the meaning set forth in Section 16.1.

“Safety Issue” means any event, report, data or information, which could cause a
re-evaluation of the safety of the Product including, but not limited to, Suspected Adverse
Drug Reaction and Unexpected Suspected Adverse Drug Reaction.

“Serious Adverse Event” means any Adverse Event in relation to any dose of the administered
Product that:

	 	A.	 	results in death;
	 
	 	B.	 	is life threatening;
	 
	 	C.	 	requires in-patient hospitalization or prolongation of existing
hospitalization;
	 
	 	D.	 	results in persistent or significant disability or incapacity; or
	 
	 	E.	 	is a congenital anomaly or birth defect.

Medical and scientific judgment should be exercised in deciding whether expedited reporting
for the Product is appropriate in other situations, such as medically important events that
may not be immediately life-threatening or result in death or hospitalization but may
jeopardize the patient or may require intervention to prevent one of the other outcomes
listed above. These should also usually be considered as Serious Adverse Events.

“Serious Suspected Adverse Drug Reaction” means any Suspected Adverse Drug Reaction in
relation to any dose of the administered Product that:

	 	A.	 	results in death;
	 
	 	B.	 	is life threatening;
	 
	 	C.	 	requires in-patient hospitalization or prolongation of existing
hospitalization;
	 
	 	D.	 	results in persistent or significant disability or incapacity; or
	 
	 	E.	 	is a congenital anomaly or birth defect.

 

 

Medical and scientific judgment should be exercised in deciding whether expedited reporting
for the Product is appropriate in other situations, such as medically important events that
may not be immediately life-threatening or result in death or hospitalization but may
jeopardize the patient or may require intervention to prevent one of the other outcomes
listed above. These should also usually be considered as Serious Suspected Adverse Drug
Reactions.

“Signal” means an unexpected observation of an event in relation to treatment with the
Product which deviates so much from expectations that it calls for immediate and greater
attention, including (but not limited to) unlabelled Suspected Adverse Drug Reactions,
increased frequency or severity of labeled Suspected Adverse Drug Reactions and any change
in the risk/benefit/profile of the Product.

“Spontaneous Report” means a communication from an individual (e.g., a health care
professional, consumer) to a company or regulatory authority that describes a Suspected
Adverse Drug Reaction or medication error. It does not include cases identified from
information solicited by the applicant or contractor, such as individual case safety
reports or findings derived from a study, company-sponsored patient support program,
disease management program, patient registry, including pregnancy registries, or any
organized data collection scheme. It also does not include information compiled in support
of class action lawsuits.

“Suspected Adverse Drug Reaction” means a noxious and unintended response to any dose of
the Product for which there is a reasonable possibility that the Product caused the
response. In this definition, the phrase “a reasonable possibility” means that the
relationship cannot be ruled out.

“Territory” has the meaning given to it in the Acquisition and License Agreement.

“Unexpected Suspected Adverse Drug Reaction” means any Suspected Adverse Drug Reaction that
is not included in the current U.S. labeling for the Product.

“Valid Safety Reports” means the minimum information required for expedited reporting
which should at least include all of the following:

	 	A.	 	an identifiable patient;
	 
	 	B.	 	a suspected medicinal product or therapeutic device;
	 
	 	C.	 	an identifiable reporter; and
	 
	 	D.	 	a Suspected Adverse Drug Reaction or an Adverse Event.

 

 

	 	 	“Warm Transfer” means the direct connection of a patient, and such patient’s name and
contact information, to an appropriate party following receipt of that patient’s initial
telephone call.
	 
	1.2	 	In this Agreement, unless the context otherwise requires:

	 	A.	 	references to “persons” includes individuals, bodies corporate (wherever
incorporated), unincorporated associations and partnerships;
	 
	 	B.	 	reference to a “Party” is to a Party to this Agreement and “Parties” is to
both of them;
	 
	 	C.	 	the headings are inserted for convenience only and do not affect the
construction of the Agreement;
	 
	 	D.	 	references to one gender includes both genders; and
	 
	 	E.	 	any reference to an enactment or statutory provision is a reference to it as
it may have been, or may from time to time be amended, modified, consolidated or
re-enacted.

	1.3	 	The Schedules comprise part of and shall be construed in accordance with the terms of this
Agreement. In the event of any inconsistency between the Schedules and the terms of this
Agreement, the terms of this Agreement shall prevail.
	 
	1.4	 	Terms used in this Agreement, which are not otherwise defined within the Agreement or the
Acquisition and License Agreement shall have the meaning given to them in accordance with FDA
Regulations or Guidelines and Shire Standard Operating Procedures (SOPs). In the event of any
conflict between Shire’s SOP’s and FDA guidelines, FDA guidelines shall prevail.
	 
	2	 	PURPOSE
	 
	2.1	 	In consideration of the mutual obligations contained in this Agreement, the Parties have
agreed to provide for the procedures relating to the exchange of safety and pharmacovigilance
information for the Product between Shire and Duramed in order to comply with worldwide
regulatory reporting requirements for the Product.
	 
	2.2	 	As between Shire and Duramed, Shire shall have the following responsibilities:

	 	a.	 	Shire shall handle all telephone calls and other communications that
it may receive regarding the items in Section 3.1, including Adverse Events and/or
Suspected Adverse Drug Reactions in accordance with the terms of this Agreement.
Except to the extent required by law, responding to private third parties
regarding complaints, notices and inquiries as to Adverse Events, Suspected
Adverse Drug Reactions, or data, documents

 

 

	 	 	 	or reports related to any of them. Shire shall process all Adverse Events and/or
Suspected Adverse Drug Reactions and prepare the data, documents or reports related
to them in a final format that is suitable for Duramed to submit to the Regulatory
Authority.

	 	b.	 	Shire shall inform Duramed within three (3) Business Days of any
communications of any kind received by Shire from any Regulatory Authority
involving safety issues in relation to the Product outside of the Territory,
although the Parties acknowledge that the Product is not sold outside of the
Territory. To the extent that Shire is required by law to respond, Shire shall,
if there is time to do so, submit its response to Duramed before submitting it to
the Regulatory Authority. Duramed will provide Shire access to Duramed’s safety
data required to respond to a Regulatory Authority request and written approval of
and/or comments on such response within a timeframe sufficient to meet any
deadlines imposed by the requesting Regulatory Authority. Shire shall, to the
extent permitted by law, cooperate fully with Duramed and keep Duramed fully
informed as to Regulatory Agency requests received by Shire within the scope of
this paragraph and Shire’s responses.
	 
	 	c.	 	Shire shall, within three (3) Business Days inform Duramed in the
event that, at any time, Shire identifies potential safety issues, including calls
or communications that Shire receives directly from, private or government, third
party in relation to the Product and will provide such further assistance, as
Shire and Duramed shall agree.

	2.3	 	Except as specifically set forth in paragraph 2.2 above, Duramed shall have following
responsibilities:

	 	a.	 	Duramed shall refer all drug safety and pharmacovigilance related
queries from healthcare providers or their staff, or any third party in relation
to the Product. The Shire contact to receive this information is identified in
Section 11.1 of this agreement as the “Appointed Medical Information Contact”.
	 
	 	b.	 	Duramed shall ensure compliance and correspond with the U.S.
Regulatory Authority on reporting requirements related to Adverse Events and
Suspected Adverse Drug Reactions, including but not limited to FDA requirements,
submission of Periodic Safety Reports, 15-day safety reports and MedWatch reports.
Duramed reserves the right to exercise final control over its submissions and
response to Regulatory Agency communications directed to, and requiring a response
from, Duramed.
	 
	 	c.	 	Duramed shall ensure that there is a mechanism available during
normal business hours to receive notices regarding any safety issue under this
Agreement;

 

 

	 	d.	 	Duramed shall handle all telephone calls and other communications
that it may receive regarding Adverse Events and/or Suspected Adverse Drug
Reactions in accordance with the terms of this Agreement;
	 
	 	e.	 	Duramed shall inform Shire within three (3) Business Days of any
communications of any kind received by Duramed from any Regulatory Authority
involving safety issues in relation to the Product in the Territory. To the
extent that Duramed is required by law to respond, Duramed shall, if there is time
to do so, submit its response to Shire before submitting it to the Regulatory
Authority. Shire will provide Duramed with safety data required to respond to a
Regulatory Authority request and written approval of and/or comments on such
response within a timeframe sufficient to meet any deadlines imposed by the
requesting Regulatory Authority. Duramed reserves the right to exercise final
control over its response to Regulatory Agency communications directed to, and
requiring a response from, Duramed, to the extent required by Duramed, in its sole
judgment, in order to maintain Duramed’s compliance with all applicable legal
requirements. Duramed shall, to the extent permitted by law, cooperate fully with
Shire and keep Shire fully informed as to Regulatory Agency requests received by
Duramed within the scope of this paragraph and Duramed responses.
	 
	 	f.	 	Duramed shall within three (3) Business Days inform Shire in the
event that, at any time, Duramed identifies potential safety issues in relation to
the Product and will provide such further assistance, as Shire and Duramed shall
agree.

	3	 	SCOPE
	 
	3.1	 	This Agreement covers:

	 	a.	 	all Spontaneous Reports of Adverse Events and Suspected Adverse Drug
Reactions in relation to the Product;
	 
	 	b.	 	all Serious Suspected Adverse Drug Reactions arising from
post-marketing surveillance with the Product;
	 
	 	c.	 	all information required for periodic reporting in relation to the
Product;
	 
	 	d.	 	all other information as required by Regulatory Authorities for the
Product; and
	 
	 	e.	 	the provision of Medical Information to support third party
inquiries.

 

 

	4	 	LANGUAGE OF ALL EXCHANGE AND TERMINOLOGY
	 
	4.1	 	The language of all information exchanged pursuant to this Agreement, including reports to
Regulatory Authorities, shall (unless specifically stated otherwise) be in English, or if any
other language, accompanied by a translation into English. In the event of any conflict
between the English text and the text in any other language, the English text shall prevail.
	 
	5	 	CONTACT PERSONNEL AND METHODS FOR ADVERSE EVENT TRANSMISSION
	 
	5.1	 	The names and details of contact personnel for Shire and Duramed are detailed in Schedule 1.
	 
	5.2	 	Any changes in names or details of any of the contact personnel for a Party in relation to
the Product must be notified by that Party to the other Party in writing to the address set
out in Schedule 1 as soon as reasonably practicable after the change occurs.
	 
	5.3	 	Any notice given under this Agreement shall be in writing and (i) personally delivered or
(ii) sent by fax or (iii) e-mail to the address of the other Party as set out in Schedule 1
(or such other address as may have been notified in writing from time to time by a Party to
the other Party) and any such notice shall be deemed to have been served at the time of
delivery (if personally delivered) or upon receipt of confirmation of transmission by the
sender’s fax machine (if sent by fax) and in the case of email upon receipt of delivery
confirmation by the sender’s computer (if sent by e-mail).
	 
	6	 	SAFETY DATABASE
	 
	6.1	 	The safety information generated pursuant to this Agreement shall be added to the safety
database for the Product and shall be held and maintained by Shire and shall be the central
repository for all drug safety information received worldwide for the Product.
	 
	6.2	 	The safety database shall be used for all drug safety and pharmacovigilance regulatory
responses and purposes for the Product.
	 
	6.3	 	Shire shall provide all safety information reasonably requested by Duramed from Shire’s
safety database to provide a response to answer any drug safety and pharmacovigilance related
queries in relation to the Product and to meet all regulatory requirements. Shire will provide
the information within a reasonable timeline according to the urgency of request. Upon
termination of this Agreement, Shire shall transfer the safety database for the Product to
Duramed as soon as reasonably practicable.

 

 

	6.4	 	With the exception of FDA exchange, which may be implemented at some future point in time,
and except as otherwise set forth herein, Duramed shall not have direct access to the safety
database for security and data privacy reasons.
	 
	7	 	EXCHANGE OF ADVERSE EVENT AND SUSPECTED ADVERSE DRUG REACTION INFORMATION
	 
	7.1	 	All notification and response periods referred to in this Agreement (unless otherwise
specified) will be in calendar days in accordance with FDA regulations.
	 
	7.2	 	The relevant period for any notification or response for either Party (including their
Representatives) will commence on the Awareness Date.
	 
	7.3	 	Duramed will attempt to Warm Transfer all calls related to the Product covered in Section 3.1
including Adverse Event and Suspected Adverse Drug Reactions calls to Shire at (888) 300-6414
at the time of receipt. Prior to transferring the call, Duramed staff will obtain a name and
contact number. If the Warm Transfer is not successful, Duramed will fax the caller’s name and
contact information to Shire’s Pharmacovigilance Department at (866) 557-4473 within two
Business Days of receipt. Shire will be responsible for the intake of the Adverse Events and
Suspected Adverse Drug Reactions and preparing MedWatch reports for any Adverse Reaction
occurring. All written Adverse Events and Suspected Adverse Drug Reactions received by Duramed
will be forwarded to Shire within two Business Days of receipt. If Shire directly receives
calls related to the Product that is an Adverse Event or Suspected Adverse Drug Reactions,
Shire will inform Duramed’s “Appointed Medical Information Contact” within two Business Days
of receipt
	 
	7.4	 	Shire shall ensure that there is a mechanism available 24-hour/7 days per week to receive
notices for any safety issue under this Agreement.
	 
	7.5	 	Upon receipt of any report from Duramed under Section 7.3, Shire will notify Duramed of
receipt of the report as soon as possible; however in no event longer than two Business Days
thereafter. Any report from is considered transmitted only after an acknowledgement of receipt
is received from Shire.
	 
	7.6	 	Shire will provide final written reports to Duramed by day 12 for an expedited (15 day)
report and at least 5 days prior the periodic due date in order for Duramed’s submissions to
meet all 15-day safety report and periodic/PSUR regulated timelines.
	 
	7.7	 	No later than the 15th day of each month, Shire will provide a line listing
including reported term, manufacturing number, demographics and a narrative for each report
received from Duramed the previous month.

 

 

	 	 	Reports received from Literature Reviews
	 
	7.8	 	Shire will be responsible for monitoring the worldwide scientific literature to meet global
regulatory reporting requirements and for monitoring drug safety for the Product. Once an
Adverse Event or a Suspected Adverse Drug Reaction has been identified, Shire will assess it
according to seriousness and where appropriate report it as a literature report quoting the
reference for the article for onward reporting by Duramed to the appropriate Regulatory
Authority in the Territory.
	 
	 	 	Management of Follow up information

Follow up of initial reports
	 
	7.9	 	Shire shall be responsible for all follow-up activities for any Adverse Events occurring in
the Territory.
	 
	7.10	 	Duramed shall notify Shire of any additional information it reasonably requires regarding an
Adverse Event occurring in the Territory that Shire has notified it of pursuant to this
Section 7 and Shire will use its reasonable endeavors to obtain the additional information
within two (2) Business Days. Shire shall notify Duramed of the outcome of the additional
information obtained by Shire for submission to the Regulatory Authority, if necessary.
	 
	8	 	ASSESSMENT OF ADVERSE EVENTS
	 
	 	 	Assessment of Listedness (Expectedness)
	 
	8.1	 	All Adverse Events and Suspected Adverse Drug Reactions will be reported to Shire
irrespective of any assessment regarding listedness (expectedness).
	 
	8.2	 	Shire shall be responsible for assessing all Adverse Events and Suspected Adverse Drug
Reactions in the Territory and shall determine if any report is required to be made to the
Regulatory Authorities in accordance with Section 10. Pursuant to Section 2.3, . Duramed
reserves the right to exercise final control over its submissions and response to the
Regulatory Authority communications directed to, and requiring a response from, Duramed.
	 
	9	 	SAFETY ISSUES/SIGNALS AND REGULATORY INQUIRIES INVOLVING SAFETY ISSUES
	 
	9.1	 	Shire shall, within 24 hours of it becoming aware, notify Duramed of any significant safety
issues other than individual ADRs referenced in Section 7 in relation to the Product. Shire
and Duramed shall discuss in good faith how to deal with any such significant safety issues
and shall co-operate with the reasonable requests of the other Party in relation to such
issues. Significant safety issues relating to the Product may occur as a result of a request
from a Regulatory Authority; potential changes in the risk/benefit of the Product; Product
quality

 

 

	 	 	issues that may have a clinical impact such as Product contamination or deterioration;
external influences such as media or literature and ongoing safety surveillance.
	 
	9.2	 	Shire and Duramed agree to reasonably collaborate on any labeling changes that are safety
related. Duramed is responsible for the maintenance of labeling changes to the Product and
will notify Shire of all safety related changes.
	 
	9.3	 	Should Shire become aware of any potential safety signal, Shire shall promptly notify
Duramed.
	 
	10	 	REGULATORY AUTHORITY INTERACTION
	 
	 	 	Expedited Reporting Responsibilities
	 
	10.1	 	Subject to Sections 7.6 to 7.10, Shire will be responsible for assessing the “reportability”
and submitting reports of Serious Suspected Adverse Drug Reactions for the Product (according
to current FDA regulations) to Duramed to be submitted to the Regulatory Authority.
	 
	10.2	 	Either Party shall permit the other Party or its representatives to inspect, review and audit
of its operations concerning Pharmacovigilance and adverse event collection and reporting in
line with FDA regulations, in accordance with the terms of this Agreement. Any information
obtained through such inspections, reviews and audits shall be treated as confidential
information of the audited Party. Such audits, reviews and inspections shall be conducted
during normal business hours, upon reasonable notice, and no more than once per year (other
than in an emergency situation), and in a manner that does not unreasonably interfere with
ongoing operations. The date and time of the audit will be determined and agreed on by both
parties, but shall be scheduled to occur within four (4) weeks of the audit request, unless
otherwise agreed. It is understood that Regulatory Agency inspections of each Party’s
facilities occur periodically and audits will not be conducted in such a way as to conflict
with those inspections.
	 
	 	 	Periodic Reporting
	 
	10.3	 	Shire shall prepare and submit to Duramed pursuant to Section 7.6 the Periodic Safety
Report for the Product in the Territory, according to its internal standard operating
procedures and in the format as detailed in 21CFR 314. The periodicity of the Periodic Safety
Report will be according to the International Birth Date of the Product.
	 
	10.4	 	Prior to regulatory submission, there should be discussion between the Parties to promote
harmonization and co-ordination if any safety signals or proposed amendments to the Reference
Safety Information are recommended. However, this must be achieved within the applicable
regulatory timeframe.

 

 

	11	 	MEDICAL INFORMATION/QUESTIONS
	 
	11.1	 	Duramed shall transfer all Medical Information inquiries received from third Parties in the
Territory regarding the Product to the person or persons specified in Schedule 1 (“Appointed
Medical Information Contact”).
	 
	11.2	 	If the inquiry is a request for information in connection with a report of an Adverse Event
or Suspected Adverse Drug Reaction, Duramed shall confirm to the Appointed Medical Information
Contact that the report has been notified to Shire in accordance with Sections 7.3 and 7.6.
	 
	12	 	AMENDMENTS TO THIS SAFETY AGREEMENT
	 
	12.1	 	This Safety Agreement becomes effective on the Effective Date.
	 
	12.2	 	If a Party becomes aware of any change of law or regulation which affects any of the matters
the subject of this Agreement, it shall notify the other Party of any such change. The
Parties shall promptly meet and discuss any such changes and negotiate in good faith any
amendments to this Agreement, which either Party honestly believes are necessary or desirable
as a result of such changes.
	 
	12.3	 	Revision of attachments (Schedules) will not require that this Safety Agreement be re-issued
and signed off, but shall require the written agreement of both Parties.
	 
	12.4	 	Changes in company personnel and methods of communication must be conveyed immediately to
both Parties, to ensure the correct and timely flow of information.
	 
	13	 	CONFIDENTIALITY
	 
	13.1	 	Each Party agrees and undertakes that it will treat and keep confidential all
Confidential Information, which may become known, to that Party from the other Party.
	 
	14	 	DURATION AND TERMINATION
	 
	14.1	 	This Agreement commences on the Effective Date and shall continue in force until
terminated by either Party in accordance with Section Error! Reference source not
found..
	 
	14.2	 	[*]
	 
	15	 	CONSEQUENCES OF TERMINATION
	 
	15.1	 	Articles 13, 15, 16 and 17 shall survive the termination of this Agreement.

 

 

	15.3	 	The termination or expiration of this Agreement shall not release either of the Parties from
any liability which at the time of termination or expiration has already accrued to the other
Party, nor affect in any way the survival of any other right, duty or obligation of the
Parties which is expressly stated elsewhere in this Agreement to survive such termination or
expiration.
	 
	16	 	RESOLVING DISPUTES
	 
	16.1	 	The Parties hereby agree that all disputes arising under this Agreement shall be
referred to a senior executive of Duramed and a senior executive of Shire (the
“Representatives”). If any such matter has not been resolved within fifteen
(15) Business Days of such referral to the Representatives either Party may invoke the
provisions of Section 16.2 for such dispute. No dispute resolution procedure set forth
in this Agreement shall be construed as an agreement to arbitrate under any federal or
state arbitration Law, including but not limited to the Federal Arbitration Act, and
shall not deprive a court of competent jurisdiction from resolving any dispute arising
under, or related to, this Agreement.
	 
	16.2	 	Any dispute that is not resolved as provided in the preceding Section 16.1, whether
before or after termination of this Agreement, may be submitted by either Party only to
any court of competent jurisdiction. This Agreement shall be governed by, and construed
in accordance with, the Laws of the State of New York. The Parties unconditionally and
irrevocably agree and consent to the exclusive jurisdiction of the courts located in New
York, NY and waive any objection with respect thereto, for the purpose of any action,
suit or proceeding arising out of or relating to this Agreement or the transactions
contemplated hereby and further agree not to commence any such action, suit or
proceeding except in any such court.
	 
	16.3	 	Notwithstanding anything to the contrary in this Agreement, either Party shall have the
right to seek temporary injunctive relief in any court of competent jurisdiction as may
be available to such Party under the Laws and rules applicable in such jurisdiction with
respect to any matters arising out of the other Party’s performance of its obligations
under this Agreement.
	 
	17	 	GENERAL PROVISIONS
	 
	17.1	 	Except as expressly provided for in this Agreement, no variation to the terms of this
Agreement shall be effective unless in writing and signed on behalf of each Party by a
director or other authorised person.
	 
	17.3	 	Failure by either Party on one or more occasions to avail itself of a right conferred by this
Agreement shall not be construed as a waiver of such Party’s right to enforce such right or
any other right.

 

 

	17.4	 	This Agreement and the Acquisition and License Agreement contain the entire agreements and
understandings between the Parties and supersede all previous agreements and understandings between
the Parties with respect to the subject matter of this Agreement. In the event of a conflict
between the terms of any of the aforementioned agreements, the Acquisition and License Agreement
shall control to the extent of any inconsistency. Each Party acknowledges that, in entering into
this Agreement, it is not relying on any representation or warranty (whether made orally or in
writing) except as expressly provided in this Agreement.

 

 

     In Witness Whereof, this Agreement has been signed by the authorized representatives of the
Parties on the day and year first written above.

	 	 	 	 	 	 	 	 	 
	SIGNED for and on behalf of

	 	 	)	 	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 	 	 	 	 
	SHIRE DEVELOPMENT, INC.

	 	 	)	 	 	Signature
	 	 
	 
	 	 	 	 	 	CEO	 	 
	 

	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Print Name and Title	 	 
	 
	 	 	 	 	 	 	 	 
	SIGNED for and on behalf of

	 	 	)	 	 	/s/ Fred Wilkinson	 	 
	 

	 	 	 	 	 	 	 	 
	DURAMED PHARMACEUTICALS, INC	 	Signature	 	 
	 
	 	 	 	 	 	President & C.O.O.	 	 
	 

	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Print Name and Title	 	 

[Signature Page to Pharmacovigilance Agreement]

 

 

SCHEDULE 1

Contact Information

 

 

EXHIBIT B

TRADEMARK LICENSE AGREEMENT

          This TRADEMARK LICENSE AGREEMENT (this “Agreement”) is entered into as of August 14,
2006, by and among Shire LLC, a Kentucky limited liability company (together with its Affiliates,
“Shire”), and Duramed Pharmaceuticals, Inc., a corporation organized and existing under the
laws of Delaware (“Duramed”) (each a “Party” and collectively, the
“Parties”).

RECITALS

          WHEREAS, Shire is in the business of formulating, manufacturing, marketing and distributing
the pharmaceutical product known as Adderall IRTM and owns the pharmaceutical product known as
Adderall IRTM;

          WHEREAS, pursuant to that certain Product Acquisition and License Agreement, executed
concurrently herewith (the “Product Acquisition Agreement”) Shire is selling to Duramed
certain rights to the Adderall IRTM product and certain assets relating to the Adderall Business (as
defined in the Product Acquisition Agreement);

          WHEREAS, pursuant to the terms and conditions of this Agreement, Shire desires to license to
Duramed, and Duramed desires to acquire, a license to use certain trademark rights related to the
Adderall Business; and

          WHEREAS, the execution of this Agreement is a condition of the Parties entering into the
Product Acquisition Agreement.

          NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in this
Agreement and in the Product Acquisition Agreement, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE I

DEFINITIONS

          1.1 Any capitalized terms used but not otherwise defined in this Agreement shall have the
meanings set forth in the Product Acquisition Agreement. The following capitalized terms shall
have the following meanings when used in this Agreement:

          1.2 “Affiliate” means a Person that, directly or indirectly, through one or more
intermediates, controls, is controlled by, or is under common control with, the Person specified.
For the purposes of this definition, control shall mean the direct or indirect ownership of (a) in
the case of corporate entities, securities authorized to cast more than fifty percent (50%) of the
votes in any election for directors, (b) in the case of non-corporate entities, more than fifty
percent (50%) ownership interest with the power to direct the management and policies of such
non-corporate entity, or (c) such lesser percentage as may be the maximum percentage allowed

 

 

           to be owned by a foreign corporation under the applicable laws or regulations of a particular
jurisdiction of the equity having the power to vote in the election of directors or to direct the
management and policies of such Person.

          “Licensed Activities” shall mean the manufacture, advertising, marketing, promoting,
selling and distributing of the Product.

          “Licensed Marks” shall mean the trademarks set forth on the attached Schedule A.

          “Losses” means any and all liabilities, damages, fines, penalties, deficiencies,
losses and expenses (including interest, court costs, amounts paid in settlement, reasonable fees
of attorneys, accountants and other experts or other reasonable expenses of litigation or other
proceedings or of any claim, default or assessment); provided, however, that the term “Losses”
shall not include any special, consequential, indirect, punitive or similar damages, except to the
extent actually paid by a Party pursuant to any Third Party Claim.

          “Product” shall mean the pharmaceutical product in all dosage forms identified in NDA
# 11-522, as may be amended or supplemented from time-to-time in accordance with applicable law.

          “Promotional Materials” shall mean any materials used in connection with the Licensed
Activities, including web sites, press releases, finished and unfinished commercials, and copies of
related text and story boards, and other content, for all television, radio, online, print or other
advertisements, and all packaging, labels, documentation and all other materials that either
include any of the Licensed Marks or are used or distributed in connection with a Product.

          “Person” shall mean an individual or a corporation, partnership, trust, incorporated
or unincorporated association, joint venture, joint stock company, government (or an agency or
political subdivision thereof) or other entity of any kind.

          “Term” shall have the meaning set forth in Article IV of this Agreement.

          “Territory” shall mean the United States, and its territories and possessions.

ARTICLE II

TERMS AND CONDITIONS

          2.1 Grant of License. Subject to the terms and conditions of this Agreement, Shire
grants to Duramed an exclusive, fully-paid-up, royalty-free, license during the Term of this
Agreement to use the Licensed Marks in connection with the Licensed Activities in the Territory.
During the Term of this Agreement, Shire shall have no right to license any third party to use any
Licensed Mark, or to use any Licensed Mark itself or through any of its Affiliates, in connection
with an oral immediate release mixed amphetamine salt pharmaceutical product or other oral
immediate release pharmaceutical product for treating Attention Deficit Hyperactivity Disorder.

2

 

          2.2 Limitations on Use. All rights not expressly granted to Duramed under this
Agreement are reserved to Shire. Without limiting the generality of the foregoing, Duramed shall
not have the right to use any of the Licensed Marks: (i) other than in connection with the
Licensed Activities, (ii) as a trade name, Duramed name, or fictitious business name, or (iii)
other than in accordance with this Agreement. Duramed shall not use or authorize any other Person
to use the Licensed Marks outside the Territory during or after the Term.

          2.3 Ownership. As between the Parties, Shire owns all right, title and interest in
and to the Licensed Marks and the goodwill associated with the Licensed Marks, and any use of the
Licensed Marks by Duramed and any associated goodwill shall inure to the benefit of Shire. Except
as expressly set forth in this Agreement, Duramed shall have no right, title or interest in or to
the Licensed Marks. Duramed shall not, during or after the Term, in any jurisdiction: (i)
challenge Shire’s title or rights in and to the Licensed Marks, or the validity of the Licensed
Marks or any applications and registrations thereof, or (ii) register, attempt to register or
assist any Person other than Shire in registering, any of the Licensed Marks or any confusingly
similar variations thereof. In no event shall Duramed use any of the Licensed Marks in a manner
that may tarnish or disparage Shire or Shire’s rights in any of the Licensed Marks.

          2.4 Marking. All Promotional Materials shall clearly state that Shire owns the
Licensed Marks. Duramed shall use the following form of such notice, in a clearly visible or
audible (as appropriate) manner: “ADDERALL® is a registered trademark of Shire LLC,
used under license.” Duramed shall have the right to use the Licensed Marks in combination with
other marks, names or symbols of Duramed without Shire’s consent (so long as they do not include
terms identical or confusingly similar to terms that Shire uses).

          2.5 Protection of the Licensed Marks. At Shire’s request and sole expense, Duramed
shall cooperate fully and in good faith with Shire in securing, protecting, enforcing and defending
Shire’s rights in the Licensed Marks. Without limiting the generality of the foregoing, Duramed
shall execute any and all documents, and take any actions, as deemed necessary in the reasonable
opinion of Shire, to confirm or otherwise establish or maintain the validity, or enforceability of,
and Shire’s rights in and to, the Licensed Marks.

          2.6 Domain Name. Shire acknowledges that Duramed shall have the right to register and
maintain a web site at www.adderallir.com. Upon termination of this Agreement, Duramed shall
transfer to Shire any domain names that incorporate any of the Licensed Marks.

          2.7 Quality Control Standards. Duramed shall maintain the quality of the Product at
the same or better level of quality as the therapeutic equivalent of the Product marketed by Barr
Laboratories, Inc. under ANDA No. 40-422 as of the Effective Date and comply materially with all
applicable laws and regulations governing the provision of the Product. Duramed shall not alter or
modify the Licensed Marks in any way. As long as this Agreement is in effect, Duramed shall provide
to Shire representative samples of the Product and Promotional Materials pursuant to Shire’s
request; provided that such request shall not be made more than once every six (6) months.

3

 

ARTICLE III

INFRINGEMENT

          3.1 If Shire or Duramed becomes aware of infringement of any Licensed Marks by a third party,
such Party shall promptly notify the other Party in writing to that effect. If, prior to the
expiration of ninety (90) days from said notice, Shire has not obtained a discontinuance of such
infringement or brought suit in the Territory against the third party infringer and such
infringement is relevant in a material respect to the Product, then Duramed shall have the right to
bring suit against such infringer and join Shire as a party. The foregoing shall not preclude the
Parties from jointly seeking such discontinuance or bringing suit and, in any event, each Party
will cooperate with the other in any suit and will have the right to consult with the other and be
represented by its own counsel at its own expense. Prior to disposition of any moneys recovered,
the expenses of the Parties in bringing suit shall be reimbursed out of the moneys recovered, with
the Party bringing the suit being reimbursed first, then the remainder, if any, of moneys recovered
by either Party upon final judgment or settlement of any infringement suit shall be retained by the
Party bringing the suit. No settlement by a Party bringing a suit shall diminish the rights or
interests of the other Party without the other Party’s written consent.

ARTICLE IV

TERM AND TERMINATION

          4.1 Term. This Agreement shall commence on the Effective Date and shall continue for
an initial term of ten (10) years (the “Initial Term”). This Agreement shall automatically
renew for successive additional ten (10) year terms (each a “Renewal Term”) unless earlier
terminated in accordance with this Article IV (the Initial Term, together with any successive
Renewal Terms, being the “Term”).

          4.2 Termination for Cause. Shire may terminate this Agreement at any time in the
event Duramed materially breaches this Agreement and such material breach continues uncured for a
period of 180 days after written notice thereof; provided, however, in the event
Duramed has in good faith commenced cure within such 180 day period, but cannot practically
complete such cure within such 180 day period, Duramed shall have an additional 180 day cure
period. In the event a material breach of this Agreement is incapable of cure, without limiting
any other rights of Shire, including the right to seek injunctive relief, Shire shall not have the
right to terminate this Agreement if (i) Duramed is providing full cooperation to mitigate the
breach, and (ii) the breach was not caused by the willful misconduct by Duramed.

          4.3 Non-Use. Shire may terminate this Agreement on written notice to Duramed if
Duramed ceases using the Licensed Marks in connection with the Licensed Activities for a period of
two (2) years or more.

          4.4 Upon Termination. Upon any termination of this Agreement by either Party for any
reason: (i) all rights granted to Duramed shall immediately terminate, and (ii) Duramed shall
immediately cease all use of the Licensed Marks.

4

 

ARTICLE V

LIMITED WARRANTIES, DISCLAIMER AND LIMITATIONS

          5.1 Mutual Representations. Each Party hereby represents and warrants to the other
Party as follows:

          (a) Due Authorization. Such Party is a corporation duly incorporated and in good
standing (where such concept applies) as of the Effective Date, and the execution, delivery and
performance of this Agreement by such Party have been duly authorized by all necessary action on
the part of such Party.

          (b) Due Execution. This Agreement has been duly executed and delivered by such Party
and constitutes a legal, valid and binding obligation of such Party, enforceable against such Party
in accordance with its terms.

          (c) No Conflict. Such Party’s execution, delivery and performance of this Agreement
do not: (i) violate, conflict with or result in the breach of any provision of the charter or
by-laws (or similar organizational documents) of such Party; (ii) conflict with or violate any law,
rule, regulation or governmental order applicable to such Party or any of its assets, properties or
businesses; or (iii) conflict with, result in any breach of, constitute a default (or event which
with the giving of notice or lapse of time, or both, would become a default) under, require any
consent under, or give to others any rights of termination, amendment, acceleration, suspension,
revocation or cancellation of any agreement to which it is a party.

          (d) Duly Licensed. Such Party is duly licensed, authorized or qualified to do
business and is in good standing (where such concept applies) in every jurisdiction in which a
license, authorization or qualification is required for the ownership or leasing of its assets or
the transaction of business of the character transacted by it, except where the failure to be so
licensed, authorized or qualified would not have a material adverse effect on such Party’s ability
to fulfill its obligations hereunder.

          5.2 Shire Representations and Warranties. Shire hereby represents and warrants to
Duramed that, as of the Effective Date:

          (a) There is no action or proceeding pending or, to Shire’s knowledge, threatened, with
respect to any Licensed Marks. There are no material unsatisfied judgments or outstanding orders,
injunctions, decrees, stipulations or awards (whether rendered by a court, an administrative agency
or by an arbitrator) against Shire or its Affiliates with respect to any Licensed Marks.

          (b) To Shire’s knowledge, the use of the Licensed Marks does not infringe or misappropriate
the intellectual property rights of any third party. Neither Shire nor any of its Affiliates has
received any written notice from any Person, or has knowledge of, any actual or threatened claim or
assertion that the use of the Licensed Marks infringes or misappropriates the intellectual property
rights of any third party.

5

 

          (c) Shire has the right to grant to Duramed the licenses set forth in this Agreement, free of
any rights or claims of any third party and without payment by Shire of any royalties, license fees
or other amounts to any Third Party.

          (d) All Licensed Marks are subsisting and, to Shire’s knowledge, valid and enforceable.

          (e) To Shire’s knowledge, there is no infringement by a third party of any Licensed Marks.

          5.3 DISCLAIMER. EXCEPT TO THE EXTENT EXPRESSLY SET FORTH IN ARTICLE V, SHIRE DOES NOT
MAKE, AND SPECIFICALLY DISCLAIMS, ANY REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE CONCERNING ANY MATTER SUBJECT TO THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT.

ARTICLE VI

INDEMNIFICATION

          6.1 Indemnification by Shire. Shire hereby agrees to hold Duramed, its Affiliates,
and their respective directors, agents and employees harmless from and against any and all Losses
arising in connection with any and all charges, complaints, actions, suits, proceedings, hearings,
investigations, claims, demands, judgments, orders, decrees, stipulations or injunctions by a third
party (each a “Third Party Claim”) resulting directly from (a) any breach by Shire of any
of its representations, warranties, covenants or obligations pursuant to this Agreement, and (b)
any claim that the use of the Licensed Marks as permitted hereunder infringes the intellectual
property rights of any third party.

          6.2 Indemnification by Duramed. Duramed hereby agrees to hold Shire, its Affiliates,
and their respective directors, agents and employees harmless from and against any and all Losses
arising in connection with any and all Third Party Claims resulting directly from (a) any breach by
Duramed of any of its representations, warranties, covenants or obligations pursuant to this
Agreement, (b) except for such matters as Shire is obligated to indemnify Duramed under 6.1, use of
the Licensed Marks in connection with Licensed Activities, including claims based on product
liability of the Product.

          6.3 Notice of Claim. All indemnification claims in respect of any indemnitee seeking
indemnity under 6.1 or 6.2 (collectively, the “Indemnitees” and each an
“Indemnitee”) shall be made solely by the corresponding Party (the “Indemnified
Party”). The Indemnified Party shall give the indemnifying Party (the “Indemnifying
Party”) prompt written notice (an “Indemnification Claim Notice”) of any Losses or the
discovery of any fact upon which such Indemnified Party intends to base a request for
indemnification under 6.1 or 6.2, but in no event shall the Indemnifying Party be liable for any
Losses that result from any delay in providing such notice which materially prejudices the defense
of such Third Party Claim. Each Indemnification Claim Notice shall contain a description of the
claim and the nature and amount of such Loss (to

6

 

           the extent that the nature and amount of such Loss are known at such time). Together with the
Indemnification Claim Notice, the Indemnified Party shall furnish promptly to the Indemnifying
Party copies of all notices and documents (including court papers) received by any Indemnitee in
connection with the Third Party Claim. The Indemnifying Party shall not be obligated to indemnify
the Indemnified Party to the extent any admission or statement made by the Indemnified Party
materially prejudices the defense of such Third Party Claim.

          6.4 Control of Defense. At its option, the Indemnifying Party may assume the defense
of any Third Party Claim subject to indemnification as provided for in under 6.1 and 6.2 by giving
written notice to the Indemnified Party within thirty (30) days after the Indemnifying Party’s
receipt of an Indemnification Claim Notice. Upon assuming the defense of a Third Party Claim, the
Indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal
counsel it selects. Should the Indemnifying Party assume the defense of a Third Party Claim, the
Indemnifying Party shall not be liable to the Indemnified Party or any other Indemnitee for any
legal expenses subsequently incurred by such Indemnified Party or other Indemnitee in connection
with the analysis, defense or settlement of the Third Party Claim.

          6.5 Right to Participate in Defense. Without limiting 6.3, any Indemnitee shall be
entitled to participate in, but not control, the defense of a Third Party Claim for which it has
sought indemnification hereunder and to employ counsel of its choice for such purpose; provided,
however, that such employment shall be at the Indemnitee’s own expense unless (a) the employment
thereof has been specifically authorized by the Indemnifying Party in writing, or (b) the
Indemnifying Party has failed to assume the defense and employ counsel in accordance with 6.3 (in
which case the Indemnified Party shall control the defense).

          6.6 Settlement. With respect to any Losses relating solely to the payment of money
damages in connection with a Third Party Claim that shall not result in the Indemnitee’s becoming
subject to injunctive or other relief or otherwise adversely affect the business of the Indemnitee
in any manner, and as to which the Indemnifying Party shall have acknowledged in writing the
obligation to indemnify the Indemnitee hereunder, the Indemnifying Party shall have the sole right
to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such
Loss, on such terms as the Indemnifying Party, in its reasonable discretion, shall deem appropriate
(provided, however that such terms shall include a complete and unconditional release of the
Indemnified Party from all liability with respect thereto), and shall transfer to the Indemnified
Party all amounts which said Indemnified Party shall be liable to pay prior to the time of the
entry of judgment. With respect to all other Losses in connection with Third Party Claims, where
the Indemnifying Party has assumed the defense of the Third Party Claim in accordance with 6.3, the
Indemnifying Party shall have authority to consent to the entry of any judgment, enter into any
settlement or otherwise dispose of such Loss provided it obtains the prior written consent of the
Indemnified Party (which consent shall be at the Indemnified Party’s reasonable discretion). The
Indemnifying Party that has assumed the defense of the Third Party Claim in accordance with 6.3
shall not be liable for any settlement or other disposition of a Loss by an Indemnitee that is
reached without the written consent of such Indemnifying Party. Regardless of whether the
Indemnifying Party chooses to defend or prosecute any Third Party Claim, no Indemnitee shall admit
any liability with respect to, or settle, compromise or discharge, any Third Party Claim without
first offering to the Indemnifying Party the opportunity to assume the defense of the Third Party
Claim in accordance with 6.3.

7

 

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

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

ARTICLE VII

MISCELLANEOUS

          7.1 Entire Agreement; Amendment. This Agreement, together with the Product
Acquisition Agreement, including the exhibits attached hereto and thereto (each of which is hereby
and thereby incorporated herein and therein by reference), set forth the complete, final and
exclusive agreement and all the covenants, promises, agreements, warranties, representations,
conditions and understandings between the Parties hereto and supersedes and terminates all prior
agreements and understandings between the Parties, which shall continue to govern the obligations
of the Parties with respect to information disclosed thereunder with respect to periods prior to
the Effective Date. There are no covenants, promises, agreements, warranties, representations,
conditions or understandings, either oral or written, between the Parties other than as are set
forth herein. No subsequent alteration, amendment, change or addition to this Agreement shall be
binding upon the Parties unless reduced to writing and signed by an authorized officer of each
Party. For the avoidance of doubt, the Parties agree that all covenants, promises, agreements,
warranties, representations, conditions, and understandings set forth herein are made and deemed
effective as of the Effective Date, and that the execution of this Agreement shall not constitute a
waiver of any right or claim of either Party as of the Effective Date.

          7.2 Notices. All notices or other communications that are required or permitted under
this Agreement shall be in writing and delivered personally, sent by facsimile (and promptly
confirmed by personal delivery or overnight courier as provided in this Agreement), or sent by
internationally-recognized overnight courier to the addresses below. Any such communication shall
be deemed to have been given (a) when delivered, if personally delivered or sent by facsimile on a
Business Day (so long as promptly confirmed by personal

8

 

           delivery or overnight courier as provided in this Agreement), and (b) on the second Business
Day after dispatch, if sent by internationally-recognized overnight courier. Unless otherwise
specified in writing, the mailing addresses of the Parties shall be as described below.

	 	 	 
	For Duramed:

	 	Duramed Pharmaceuticals, Inc.
	 

	 	400 Chestnut Ridge Road
	 

	 	Woodcliff Lake, NJ 07677
	 

	 	Phone: 201-930-3300
	 

	 	Fax: 201-930-3330
	 

	 	Attention: President
	 
	 	 
	with a copy to:

	 	Barr Pharmaceuticals, Inc.
	 

	 	400 Chestnut Ridge Road
	 

	 	Woodcliff Lake, NJ 07677
	 

	 	Phone: 201-930-3300
	 

	 	Fax: 888-843-0563
	 

	 	Attention: General Counsel
	 
	 	 
	For Shire:

	 	Shire LLC
	 

	 	725 Chesterbrook Boulevard
	 

	 	Wayne, Pennsylvania 19087-5637
	 

	 	Fax: (484) 595-8163
	 

	 	Attention: General Counsel
	 
	 	 
	with a copy to:

	 	Morgan, Lewis & Bockius LLP
	 

	 	502 Carnegie Center
	 

	 	Princeton, NJ 08540
	 

	 	Fax: (609) 919-6701
	 

	 	Attention: Randall B. Sunberg

          7.3 Independent Contractors. In making and performing this Agreement, Shire and
Duramed shall act at all times as independent contractors and nothing contained in this Agreement
shall be construed or implied for any purpose to create an agency, partnership, limited
partnership, joint venture or employer and employee relationship between Shire and Duramed and this
Agreement shall not be construed to suggest otherwise. At no time shall one Party make commitments
or incur any charges or expenses for or in the name of the other Party. Except as otherwise
provided in this Agreement, each Party shall be solely responsible for its own costs and expenses
associated with this Agreement.

          7.4 No Strict Construction. This Agreement has been prepared jointly and shall not be
strictly construed against either Party.

          7.5 Governing Law. This Agreement shall be governed by and construed under the
substantive laws of the State of New York without giving effect to the choice of law provisions
thereof.

9

 

     7.6 Assignment. Neither Party shall sell, transfer, assign, delegate, pledge or
otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this
Agreement or any of its rights or obligations under this Agreement without the prior written
consent of the other Party (which consent may be granted, withheld or conditioned at such other
Party’s sole and absolute discretion); provided, however, that either Party may assign or transfer
this Agreement or any of its rights or obligations under this Agreement without the consent of the
other Party to any Affiliate of such Party, or to any third party with which it merges or
consolidates, or to which it transfers all or substantially all of its assets to which this
Agreement pertains. The assigning Party (unless it is not the surviving entity) shall remain
jointly and severally liable with, and shall guarantee the performance of, the relevant Affiliate
or third party assignee under this Agreement, and the relevant Affiliate assignee, third party
assignee or surviving entity shall assume in writing all of the assigning Party’s obligations under
this Agreement. Any purported assignment or transfer in violation of this 7.6 shall be void ab
initio and of no force or effect.

     7.7 Counterparts. This Agreement may be executed in two counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and the same
instrument. Signatures provided by facsimile transmission shall be deemed to be original
signatures.

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

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

     7.10 Headings. The headings for each article and section in this Agreement have been
inserted for convenience of reference only and are not intended to limit or expand on the meaning
of the language contained in the particular article or section.

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

[signature page follows]

10

 

     IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be signed by their respective
representatives thereunto duly authorized, all as of the date first written above.

	 	 	 	 	 	 	 
	 	 	SHIRE PLC
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	Name:	 	Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	Title:	 	CEO	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	SHIRE LLC
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	Name:	 	Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	Title:	 	CEO	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	DURAMED PHARMACEUTICALS, INC.
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Fred Wilkinson	 	 
	 

	 	 	 	 	 	 
	 

	 	Name:	 	Fred Wilkinson	 	 
	 

	 	 	 	 	 	 
	 

	 	Title:	 	President & C.O.O.	 	 
	 

	 	 	 	 	 	 

[Signature Page to Trademark License Agreement]

11

 

SCHEDULE A

Licensed Marks

	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Serial No./	 	Reg. No./
	Mark	 	Owner	 	Country	 	Goods/Services	 	Filing Date	 	Reg. Date
	[*]

	 	[*]
	 	[*]
	 	[*]
	 	[*]
	 	[*]

1

 

EXHIBIT C

SUPPLY AGREEMENT

BETWEEN

SHIRE LLC

AND

DURAMED LABORATORIES, INC.

DATED AS OF

AUGUST 14, 2006

 

 

SUPPLY AGREEMENT

     This SUPPLY AGREEMENT (this “Agreement”), dated as of August 14, 2006, by and among
Shire LLC, a Kentucky limited liability company having a place of business at 725 Chesterbrook
Boulevard, Wayne, Pennsylvania 19087 (“Shire”), and Duramed Pharmaceuticals, Inc., a
Delaware corporation having a place of business at 400 Chestnut Ridge Road, Woodcliff Lake, NJ
07677 (“Duramed”) (each a “Party” and collectively, the “Parties”).

RECITALS

     WHEREAS, the Parties have entered into that certain Product Acquisition and License Agreement
(the “Product Acquisition Agreement”), dated as of the date hereof, pursuant to which Shire
shall sell and license to Duramed assets and rights relating to the Products (as defined in the
Product Acquisition Agreement) Shire (capitalized terms used herein but not defined herein shall
have the meanings set forth in the Product Development Agreement);

     WHEREAS, the Product Acquisition Agreement contemplates the Parties entering into this
Agreement to govern the supply of Products by Shire to Duramed; and

     WHEREAS, Shire desires to manufacture and/or supply the Products to Duramed upon the terms and
subject to the conditions of this Agreement.

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

ARTICLE I

DEFINITIONS

     “Affiliate” means, with respect to a Party, any entity that directly or indirectly
controls, is control led by, or is under common control with, such Party, but only for so long as
such control continues. For purposes of this definition, “control” means the power to direct the
management and affairs of an entity, directly or indirectly, whether through the ownership of
voting securities, by contract or otherwise. In the case of a corporation, the direct or indirect
ownership of fifty percent (50%) or more of its outstanding voting shares shall in any case be
deemed to confer control, provided that, the direct or indirect ownership of a lower percentage of
such securities shall not necessarily preclude the existence of control.

     “API Cost” for a Product means the actual cost paid by Shire on a pass-through basis
for the active pharmaceutical ingredient in such Product.

     “Changeover Plan” has the meaning set forth in Section 8.2.

     “Effective Date” shall mean the Closing Date, as such term is defined in the Product
Acquisition Agreement.

 

 

     “Force Majeure Event” has the meaning set forth in Section 9.1.

     “Losses” means any and all liabilities, damages, fines, penalties, deficiencies,
losses and expenses (including interest, court costs, amounts paid in settlement, reasonable fees
of attorneys, accountants and other experts or other reasonable expenses of litigation or other
proceedings or of any claim, default or assessment); provided, however, that the term “Losses”
shall not include any special, consequential, indirect, punitive or similar damages, except to the
extent actually paid by a Party pursuant to any Third Party Claim.

     “Manufacturing” shall mean all activities related to the manufacturing of a Product or
any component or ingredient thereof, including packaging, in-process and finished product testing,
release of product or any component or ingredient thereof, quality assurance activities related to
manufacturing and release of product, ongoing stability tests and regulatory activities related to
any of the foregoing.

     “Packaging Specifications” means the existing packaging and labeling specifications
for Product, other than changes resulting from a new NDC Number and replacement of the Shire name
with Duramed’s name, as amended or supplemented from time to time in accordance with Section 3.13.

     “Product Specifications” means the specifications for Product set forth in the Product
NDA.

     “Purchase Order” has the meaning set forth in Section 3.2.

     “Rolling Forecast” has the meaning set forth in Section 3.1.

     “Product” has the meaning set forth in the Product Acquisition Agreement.

     “Supply Price” means (a) with respect to Products included in the Initial Order, [*]

     “Term” has the meaning set forth in Section 7.1.

     “Termination Assistance Services” has the meaning set forth in Section 8.1.

ARTICLE II

SUPPLY OF PRODUCTS

     Section 2.1. Purchase of Products. Pursuant to the terms and conditions of this
Agreement, Duramed shall purchase from Shire, and Shire shall supply to Duramed Products.

     Section 2.2. Initial Forecast and Purchase Order. (a) Promptly following the date
hereof, Duramed shall submit to Shire (i) an initial non-binding forecast (the “Initial
Forecast”), which Initial Forecast shall be updated thereafter in accordance with Section 3.1;
and (ii) Duramed’s initial Purchase Order (the “Initial Order”) for Products.

2

 

     (b) Refund for Certain Product Included in the Initial Order. After the Effective
Date, Duramed will use its commercially reasonable efforts to sell the Products included in the
Initial Order on a first-in, first-out basis. In the event that any product included in the
Initial Order cannot be sold by Duramed prior to the date on which such Product has reached twelve
(12) months of remaining shelf life, Shire will reimburse Duramed for amounts paid by Duramed under
Section 6.1 of this Agreement for such unsellable Products included in the Initial Order. For
reference purposes, Schedule 3 sets forth the quantities of inventory of Products in finished goods
form held by Shire as of the date hereof.

     (c) No later than the Closing Date, Shire shall sell and deliver to Duramed such quantities of
Products reflected in such Initial Order, all in Shire labeled packaging, unless Duramed engages a
Third-Party to repackage the Product with Duramed labeling at Duramed’s sole cost and expense.
Other than the Initial Order, in no event shall Duramed submit a Purchase Order for Products less
than three (3) months prior to the required delivery date for such order.

     Section 2.3. Assignment of Shire Supply Agreement. At Duramed’s request, commencing
as of and after the date hereof, Shire shall use its commercially reasonable best efforts to
provide reasonable cooperation to assist in the assignment of Shire’s existing third party supply
agreement with respect to the Product to Duramed, including assisting Duramed in obtaining
diligence information and other data in connection with such third party supply agreement. Duramed
shall not be obligated to accept assignment of such third party supply contract other than at
Duramed’s sole option and discretion.

     Section 2.4 CBE 30 Request. As promptly as practicable (but in no event more than
three business days ) following the date hereof, Shire shall file a “CBE 30” request to designate
Duramed (or such other party as Duramed may designate in its discretion) as an alternative
packager/repackager for the Products using Duramed labels. Share shall provide reasonable
assistance, at Duramed’s costs, to assist Duramed in obtaining a minimum of [*] of saleable
finished goods inventory of the Products bearing Duramed labeling and artwork no later than two
business days following Closing.

     Section 2.5 Purchase Prior to Closing. Prior to the Effective Date, Duramed (or its
designee) shall have the option to purchase such amount of existing Shire inventory of the Products
existing and in the possession of Shire for the purpose of repackaging such inventory into finished
goods inventory bearing Duramed labeling and artwork. Any such purchase of inventory prior to the
Effective Date shall correspondingly reduce the amount of inventory Duramed is obligated to
purchase in the Initial Order pursuant to Section 2.3 hereof.

ARTICLE III

FORECASTS, ORDERS AND SHIPMENT

     Section 3.1. Forecasted Quantities. At the beginning of each calendar month following
the Initial Forecast under Section 2.3 and each month thereafter, Duramed shall provide an updated
rolling forecast of Duramed’s estimated requirements for quantities of such Product over the [*]
period commencing after the date of such forecast, with expected order amounts, order dates and
delivery dates (each such forecast a “Rolling Forecast”). Except as provided below, such
Rolling Forecasts shall represent Duramed’s reasonable estimates for

3

 

planning purposes only and shall not obligate Duramed to purchase any such quantities. Each
Rolling Forecast shall be made by Duramed in good faith, taking into account reasonable projections
of demand for Products including, without limitation, demand in line with prescription trends, and
allowing for reasonable safety stock. Shire shall use commercially reasonable efforts to ensure
sufficient manufacturing capacity to meet the Rolling Forecast. Duramed shall forecast in amounts
comprising full batch quantities for each Product. The first three (3) months of any given Rolling
Forecast for a Product delivered after the Effective Date shall be binding upon Duramed and Duramed
shall be required to issue a Purchase Order for such amount of Product. No portion of any Rolling
Forecast issued by Duramed prior to the Effective Date shall be binding upon Duramed.

     Section 3.2. Purchase Order Form. Duramed shall submit all orders for the purchase of
Products using the form of purchase order attached hereto as Schedule 1 (each a
“Purchase Order”). Each Purchase Order will be delivered to such location as Shire
designates in writing to Duramed from time to time. After Shire receives a Purchase Order, Shire
shall acknowledge receipt thereof in writing within five (5) business days, either (i) accepting
the Purchase Order, or (ii) seeking clarification of the Purchase Order, if necessary. Shire shall
have no obligation to accept any Purchase Order that does not include all information required on
Schedule 1 or that is inconsistent with the terms and conditions of this Agreement. In the
event that an order is rejected, Shire and Duramed will cooperate in good faith to resolve any
supply issues raised by such order. The minimum size of any order placed by Duramed will be a full
batch.

     Section 3.3. Delivery of Product. Upon acceptance of a Purchase Order, Shire shall
deliver all Product by the delivery date covered by such Purchase Order in accordance with the
terms of this Agreement and such Purchase Order, including the quantities accepted in each Purchase
Order. At the time of delivery to Duramed, all Product manufactured hereunder shall meet the
Product Specification applicable thereto in all material respects, and shall be finished, packaged,
labeled and/or ready for commercial sale by Duramed as required in accordance with the Packaging
Specifications.

     Section 3.4. Expedited Delivery. Upon the request of Duramed to supply the quantities
of Product under a Purchase Order on an expedited basis, Shire shall notify Duramed of any expected
increased costs that Shire anticipates it will incur. Subject to prior written approval by Duramed
of these increased costs, Shire shall use reasonable efforts to supply the quantities of Product on
an expedited basis. Shire shall not have any liability for any failure to meet any such requested
expedited delivery schedule.

     Section 3.5. Excess Purchase Orders. Shire shall use commercially reasonable efforts
to, but shall not be obligated to supply quantities of any Product in excess of 120% of the
quantities set forth in the most recent forecast for such quarter. If Shire believes it will be
unable to deliver any additional volume on the date specified by Shire in the applicable Purchase
Order, Shire shall notify Duramed in writing as promptly as practicable, and shall provide a
proposed alternative delivery schedule. Any agreement on the delivery schedule for such additional
volume shall be documented in writing and shall become effective only upon mutual written agreement
of both Parties to the terms and conditions thereof.

4

 

     Section 3.6. Cancellation of Orders. Duramed may not cancel an order without payment
to Shire in full for the order. Shire shall, in good faith, use commercially reasonable efforts to
mitigate the costs of cancellation of any Purchase Order.

     Section 3.7. Conflict. The terms of this Agreement shall prevail over any
conflicting, inconsistent or additional terms set forth in any Purchase Order.

     Section 3.8. Delivery and Risk of Loss. All Products shipped under this Agreement
will be shipped Ex-Works (Incoterms 2000) Shire’s manufacturing facility to such location
designated by Duramed in the applicable accepted Purchase Order. Duramed will pay all freight,
insurance charges, taxes, import and export duties, inspection fees and other charges applicable to
the sale and transport of Products. Risk of loss to Products shall pass to Duramed upon delivery
to Duramed’s designated carrier. Title to all Products manufactured hereunder shall pass to
Duramed on payment by Duramed for the applicable Product or pro-rata portion thereof.

     Section 3.9. Certificate of Analysis. A Certificate of Analysis (“COA”) will
accompany each shipment of Products in the form attached hereto as Schedule 2.

     Section 3.10. Location of Manufacturing. All Products shall be manufactured in a
facility that has been designated as an approved manufacturing facility by the applicable
Regulatory Approval for such Product. Should Shire desire to change any of the manufacturing site
for a Product, or any component thereof, to a site other than those designated in the applicable
Regulatory Approval, Shire shall notify Duramed in writing and the Parties shall thereafter meet to
discuss the potential consequences of such a change. Shire shall not change manufacturing sites
for any Product, or any component thereof, except in accordance with the authorization of the
applicable Governmental Authority, and the procedures and requirements set forth in this Agreement.

     Section 3.11. Shortage of Materials. In the event that the materials and/or resources
required to manufacture and deliver Products to Duramed in accordance with this Agreement are, or
are reasonably anticipated to become, in short supply such that Shire may be unable to provide
Duramed with the quantities of Products set forth in a Purchase Order, Shire shall notify Duramed
of such shortage as promptly as practicable. If Shire so notifies Duramed, Shire and Shire shall
promptly meet to discuss how to address the potential shortage. In the event that Shire, at any
time, has any information indicating that it may not be able to supply Duramed with all Products in
accordance with a confirmed Purchase Order, Shire shall as soon as practicable provide Duramed a
written notice to that effect. Any failure by Shire to meet its obligations under this Agreement
as a result of a general shortage of raw materials shall not be considered a breach of this
Agreement provided that Shire is meeting its obligations under Article IX. To the extent (other
than as a result of a Force Majeure Event) that Shire fails to supply at least 80% of the
quantities of Product in the aggregate ordered for a particular calendar quarter for two
consecutive calendar quarters, Duramed may request and Shire shall, at its cost and expense,
qualify a second source of supply. Such second source shall be qualified and ready to manufacture
Product within 12 months following such Duramed request. If Shire fails to qualify and have ready
such second source, then Duramed shall have the right to qualify and make ready such second source
and Shire shall promptly reimburse Duramed for costs and

5

 

expenses incurred by it in so doing. Such second source shall be used by Shire to supply
Product to Duramed under this Agreement at least to the extent required to maintain the second
source as a qualified manufacturer of Product.

     Section 3.12. Product Specifications. Shire shall manufacture all Product so
that, at the time of delivery to Duramed, the Product conforms, in all material respects, to the
Product Specifications, cGMP and any reasonable requests communicated by Duramed to Shire in order
for Duramed to comply with any legal or regulatory obligations applicable to Duramed. At the time
of shipment of Products, the Products shall have a minimum remaining shelf life of not less than 18
months. On mutual agreement of the Parties, the Parties may modify the Product Specifications of
the Product by amendment, unless such changes are required by any regulatory authority, in which
case Duramed may unilaterally modify the Product Specifications of the Product. Upon modification
of such Product Specifications, Shire shall use commercially reasonable efforts to alter its
manufacturing processes to meet such Product Specifications and shall not be liable for any failure
to meet its obligations hereunder while acting in good faith to meet the new Product
Specifications.

     Section 3.13. Packaging Specifications. After the initial Purchase Order, Shire shall
package all Products in accordance with the Packaging Specifications. Changes in the Packaging
Specifications shall be subject to the mutual agreement of the Parties on a schedule to be agreed
by the Parties, taking into account the time and cost required for Shire to implement any necessary
manufacturing or packaging modifications. Duramed shall compensate Shire for the cost of any
inventory of old packaging that cannot be used as a result of any modification by Duramed to the
Packaging Specifications, and for any other costs incurred as a result of the implementation of the
modifications to the Packaging Specifications requested by Duramed. Duramed will be responsible
for ensuring the accuracy of all information contained on all labels for Products and for the
compliance of all such labels with applicable Laws and Regulatory Approvals.

     Section 3.14. Facility Maintenance; Inspection; Reports. Shire shall, at all times,
maintain and operate all facilities where Products are manufactured, packaged or tested, and
implement required quality control procedures to perform its obligations under this Agreement. Not
more than once every [*] (or more often in the case of a deficiency), Shire shall permit, or cause
its contractors to permit, quality assurance representatives of Duramed or designated third parties
and representatives of the applicable Government Authority to inspect such facilities upon
reasonable advance notice, during normal business hours and on a confidential basis. Shire shall
promptly provide, or cause its contractor to provide, Duramed with a copy of any notice from the
applicable Government Authority received at the conclusion of an inspection relating to any
Product.

     Section 3.15. Subcontracting. Shire shall have the right to subcontract manufacture
and supply under this Agreement to any Affiliate of Shire or to a Third Party, provided
that, (i) Shire shall procure that such Affiliates and Third Parties comply with the terms and
conditions of this Agreement, (ii) Shire shall be liable for any non-performance or breach by such
Affiliate or Third Party, and (iii) any subcontracting to a Third Party shall be subject to
Duramed’s approval, which approval shall not be unreasonably withheld.

6

 

     Section 3.16. Competing Products. Subject to the Product Development Agreement, each
of the Parties recognizes and acknowledges that the other and/or its Affiliates have been, and will
continue to be, actively involved in the field in which the Products may be sold. Each Party
acknowledges that the other Party and/or its Affiliates currently, or may in the future, market,
sell and distribute products that compete directly with any Product, and may continue to market,
sell and distribute these and other competing products throughout the Term of this Agreement.

ARTICLE IV

REPRESENTATIONS AND WARRANTIES

     Section 4.1. Mutual Representations. Each Party hereby represents and warrants to the
other Party, as of the date hereof, as follows:

     (a) Due Authorization. Such Party is a corporation duly incorporated and in good
standing (where such concept applies) as of the Effective Date, and the execution, delivery and
performance of this Agreement by such Party have been duly authorized by all necessary action on
the part of such Party.

     (b) Due Execution. This Agreement has been duly executed and delivered by such Party
and constitutes a legal, valid and binding obligation of such Party, enforceable against such Party
in accordance with its terms.

     (c) No Conflict. Such Party’s execution, delivery and performance of this Agreement
do not: (i) violate, conflict with or result in the breach of any provision of the charter or
by-laws (or similar organizational documents) of such Party; (ii) conflict with or violate any law,
rule, regulation or governmental order applicable to such Party or any of its assets, properties or
businesses; or (iii) conflict with, result in any breach of, constitute a default (or event which
with the giving of notice or lapse of time, or both, would become a default) under, require any
consent under, or give to others any rights of termination, amendment, acceleration, suspension,
revocation or cancellation of any agreement to which it is a party.

     (d) Duly Licensed. Such Party is duly licensed, authorized or qualified to do
business and is in good standing (where such concept applies) in every jurisdiction in which a
license, authorization or qualification is required for the ownership or leasing of its assets or
the transaction of business of the character transacted by it, except where the failure to be so
licensed, authorized or qualified would not have a material adverse effect on such Party’s ability
to fulfill its obligations hereunder.

ARTICLE V

QUALITY ASSURANCE

     Section 5.1. Shire Compliance. Shire shall manufacture, fill, package, handle and
warehouse the Products in conformity with all applicable laws, cGMP requirements and the Product
Specifications. Duramed shall maintain all Regulatory Approvals and all permits and licenses
issued by any Governmental Authority that are necessary to permit Shire to manufacture and supply
the Products. Shire shall advise Duramed of any information of which it becomes

7

 

aware arising out of Shire’s activities hereunder that have adverse regulatory compliance
and/or reporting consequences affecting the Products.

     Section 5.2. Inspections. Shire shall advise Duramed of any requests by any
Governmental Authority for inspections of the premises used to manufacture Products. In the event
the portion of Shire’s facilities at which Product are manufactured is inspected by any
Governmental Authority, Shire shall use commercially reasonable efforts to ensure that Duramed
shall have the right to be present during such inspection. To the extent relating directly to a
Product, Shire shall notify Duramed of any alleged violations or deficiencies relating to a
facility at which any Products are manufactured, packaged or stored, and, to the extent relating
directly to a Product, shall disclose to Duramed all relevant portions of any notice of
observations or potential violations as well as a copy of its response thereto.

     Section 5.3. Duramed Compliance. Duramed shall hold, store, handle, ship, deliver,
distribute and/or sell the Products (i) in accordance with applicable cGMP requirements, laws and
Regulatory Approvals; and (ii) in compliance with the Product Specifications. Duramed shall enter
into all necessary compliance agreements as may be reasonably required or designated by Shire,
including but not limited to the quality agreement attached hereto as Exhibit A (the “Quality
Agreement”) and any other agreements to cover quality assurance and adverse incident reporting,
including the safety agreement.

     Section 5.4. Quality Control. Upon delivery of Products to Duramed, Duramed shall be
solely responsible for compliance with all Laws and Regulatory Approvals with respect to the
Products.

     Section 5.5. Rejection of Delivered Products. Within [*] of receipt of any Product,
Duramed shall inspect the Product and advise Shire of any defect whereby the Product does not
conform to the Product Specifications. Any Product not refused within [*] shall be deemed accepted
subject to Section 5.6 below; provided, however, that such acceptance or deemed
acceptance shall not adversely affect any claim for indemnification provided in Article XI. If
Duramed desires to refuse acceptance, Duramed shall, within such [*] period, inform Shire of its
refusal to accept the defective Product and the reason(s) therefor. In the event that Duramed
refuses acceptance, Shire, upon confirmation of the reasons for refusal of the Product, will
replace the defective Product or refund the purchase price thereof, at Duramed’s option. If Shire
and Duramed do not agree on the refusal or rejection of Product, then any Party may refer the
matter for final analysis to a specialized laboratory of national reputation acceptable to both
Parties for the purpose of determining the results. Any determination by such laboratory shall be
final and binding upon the Parties. The cost of any such review by a laboratory shall be borne by
Duramed if it is determined that the Product conforms to the Product Specifications, and by Shire
if determined that it does not.

     Section 5.6. Latent Defects. Duramed shall have the right to refuse and reject any
Collaboration Product within [*] from the date Duramed becomes aware of a defect in a Product
delivered hereunder, in the case of defects that are not evident upon a reasonable initial
inspection but which subsequently become evident.

8

 

     Section 5.7. Non-Conforming Products. Notwithstanding any other provisions of this
Agreement, Duramed shall return to Shire or its designee any Products that do not conform with the
Product Specifications at the time of shipment to Duramed, or if Duramed and Shire mutually agree,
to dispose of such Products as Shire may direct. Shire shall be responsible for the costs
associated with the proper disposal of all such Products not in conformance with the Product
Specifications at the time of shipment and shall promptly replace or credit, at the option of
Shire, such non-conforming Products.

     Section 5.8. Cost of Recall. In the event that any Product is quarantined or
recalled, or is subject to a stop-sale action, whether voluntary or by the action of any
Governmental Authority, or as a result of the revocation or expiration of any Regulatory Approval,
any expenses, including any out-of-pocket administrative costs and reasonable fees of any experts
or attorneys that may be utilized by either Party, government fines or penalties, related to such
recall, quarantine or stop-sale, shall be borne by Duramed unless it is determined that the reason
for the quarantine, recall or stop-sale action is the result of the breach by Shire of its
obligations under this Agreement, and in such case such expenses shall be shared according to the
relative responsibility of each Party. Such determination may be made by the Governmental
Authority involved, or by mutual agreement of the Parties following examination and review of all
records pertinent to the manufacture of the Product subject to such recall.

     Section 5.9 Regulatory Actions. If any regulatory authority in the Territory takes
any action with respect to a Product that requires a response or action by Shire, Shire shall use
commercially reasonable efforts, at the expense of Duramed, to carry out the response or action, at
all times in consultation with Duramed, and promptly thereafter Shire shall meet with Duramed and
agree a suitable plan of action in order to try and rectify and/or address any problem(s)
identified by the Regulatory Authority within a reasonable period of time at the expense of
Duramed. Notwithstanding the foregoing, if any of the above expenses result from Shire’s breach,
negligence or willful misconduct hereunder, then any expenses incurred under this Section 5.9 shall
be Shire’s responsibility.

ARTICLE VI

PRICE AND PAYMENTS

     Section 6.1. Supply Prices. The unit price payable by Duramed for each Product shall
be [*].

     Section 6.2. Unit Price Negotiation. [*]

     Section 6.3. Records, Audit. Shire shall keep complete and accurate records,
consistent with GAAP, of the Supply Price. Duramed shall have the right to have an independent
certified public accounting firm of internationally recognized standing, reasonably acceptable to
Shire, to have access during normal business hours, and upon reasonable prior written notice, to
such of the records of Shire as may be reasonably necessary to verify the accuracy of amounts paid
by Duramed under this Agreement for any calendar year ending not more than three (3) years prior to
the date of such request; provided, however, that, Duramed shall not have the right to conduct more
than one such audit in any twelve (12) month period and that Duramed shall not be permitted to
audit the same period of time more than once. The

9

 

accounting firm shall disclose to Duramed only whether the various expenses subject to
reimbursement under this Agreement are correct or incorrect and the specific details concerning any
discrepancies. Duramed shall bear all costs of such audit, unless the audit reveals a discrepancy
in Duramed’s favor of more than[*], in which case Shire shall bear the cost of the audit. If Shire
disputes the findings pursuant to this Section 6.3, the Parties shall meet and discuss such
dispute. If such dispute is not resolved within forty-five (45) days, then it shall be subject to
the dispute resolution provisions contained herein.

     Section 6.4. Invoices. Shire may invoice for Product at any time following tender
thereof to Duramed’s carrier. All invoices shall be sent to a single address specified in writing
by Duramed. Payment for Product shall be due within forty-five (45) days after the date of the
invoice by check or electronic funds transmission in United States dollars without any offset or
deduction of any nature whatsoever. All electronic payments shall be made to such account as Shire
shall have specified in writing to Duramed with written confirmation of payment sent by facsimile
to such address as Shire shall have specified in writing to Duramed. If Duramed fails to pay any
undisputed invoiced amount when due, a service charge will be imposed by Shire equal to [*].

     Section 6.5. Taxes. The Supply Price shall be exclusive of any applicable value added
tax and any other taxes, duties and impositions that, if applicable, shall be paid by Duramed to
Shire at the same time as the purchase price for such Product. Duramed shall bear the cost of any
such taxes, duties or impositions of any kind, nature or description applicable to the sale and
transportation of Product, and Duramed will forthwith pay to Shire all such amounts upon demand.

     Section 6.6. Separate Sale. Each shipment of Product shall constitute a separate
sale, obligating Duramed to pay therefor, whether such shipment is in whole or only partial
fulfillment of any Purchase Order.

     Section 6.7. Deductions. Duramed shall not to make any deductions of any kind from
any payments due to Shire hereunder unless Duramed will have received prior written authorization
from Shire authorizing such deduction.

     Section 6.8. Audit.

     (a) Audit. Duramed shall have the right to have an independent certified public
accounting firm of internationally recognized standing, reasonably acceptable to Shire, to have
access during normal business hours, and upon reasonable prior written notice, to such of the
records of Shire as may be reasonably necessary to verify the accuracy of amounts paid by Duramed
under this Agreement for any calendar year ending not more than [*] prior to the date of such
request; provided, however, that, Duramed shall not have the right to conduct more than one such
audit in any [*] period and that Duramed shall not be permitted to audit the same period of time
more than once. The accounting firm shall disclose to Duramed only whether the various expenses
subject to reimbursement under this Agreement are correct or incorrect and the specific details
concerning any discrepancies. Duramed shall bear all costs of such audit, unless the audit reveals
a discrepancy in Duramed’s favor of more than [*], in which case Shire shall bear the

10

 

cost of the audit. If Shire disputes the findings pursuant to this Section 6.8, the Parties
shall meet and discuss such dispute.

     (b) Payment of Additional Amounts. If, based on the results of any audit, (a)
additional payments are owed by Duramed to Shire under this Agreement, then Duramed shall make such
additional payments, or (b) the payments previously made by Duramed to Shire under this Agreement
are in excess of the amounts that were actually required to be made, then Shire shall return such
excess payments, in each case within fifteen (15) Business Days after the accounting firm’s written
report is delivered to the Parties.

ARTICLE VII

TERM AND TERMINATION

     Section 7.1. Term. Subject to the occurrence of the Closing, the term of this
Agreement shall commence on the Effective Date and shall continue until terminated in accordance
with this Article VII (the “Term”). Duramed may terminate this Agreement as to the supply
of particular Product at any time on six (6) months written notice to Shire. Subject to Article
VIII, Shire may terminate this Agreement as to the supply of particular Product at any time on
eighteen (18) months written notice to Duramed, provided that Shire may not terminate this
Agreement under this sentence until ten (10) years following the Effective Date. Termination of
this Agreement with respect to one or more Products shall not relieve the Parties of any
obligations with respect to any other Products, and this Agreement shall remain in effect as to
such other Products.

     Section 7.2. Termination Upon Assignment. Duramed shall also have the right to
terminate this Agreement in the event that Shire’s existing Third Party supply agreement is
assigned to Duramed, effective immediately upon the effectiveness of such assignment but subject to
Section 7.4.

     Section 7.3 Termination for Cause. Either Party may terminate this Agreement as to
the supply of a particular Product at any time in the event that the other Party materially
breaches this Agreement and such material breach continues uncured for a period of ninety (90) days
after written notice thereof; provided, however, in the event that the breaching
Party has in good faith commenced cure within such ninety (90) day period, but cannot practically
complete such cure within such ninety (90) day period, the breaching Party shall have an additional
ninety (90) day cure period. In the event a material breach of this Agreement is incapable of cure
or cannot be cured in the time periods set forth in the previous sentence acting using commercially
reasonable efforts, without limiting any other rights of the non-breaching Party, including the
right to seek injunctive relief, the non-breaching Party shall not have the right to terminate this
Agreement if (i) the breaching Party is providing full cooperation to resolve and/or mitigate the
breach, and (ii) the breach was not caused by willful misconduct by the breaching Party.

     Section 7.4. Survival. The provisions of Sections 5.8 and 7.4, and Articles VIII, X,
XI and XII shall survive termination or expiration of this Agreement. Termination of this
Agreement shall not affect the obligation of any Party to pay the other Party any amounts due
hereunder accrued prior to the termination date hereof. Except in the event of termination by
Shire under Section 7.3, upon termination of this Agreement Shire shall deliver to Duramed on

11

 

an ex-works basis all manufactured and work-in progress quantities of Product in its
possession that have been manufactured in respect of a specific Purchase Order(s) accepted by Shire
hereunder subject to payment in advance therefor by Duramed. The right to terminate this Agreement
shall not prejudice any other right or remedy in equity or at law of a Party in respect of any
breaches of this Agreement.

ARTICLE VIII

TERMINATION ASSISTANCE SERVICES

     Section 8.1. Termination Assistance Services. If (i) Shire terminates this Agreement
as to the supply of Product under Section 7.1 (and Duramed intends to continue marketing and
selling the Product), or (ii) Duramed terminates this Agreement under Section 7.1 or 7.2 (and
Duramed intends to continue marketing and selling the Product), Shire shall for a period of one (1)
year thereafter, upon Duramed’s request, provide any cooperation reasonably requested by Duramed
that may be required to facilitate the transfer of the manufacture of the applicable Product to
Duramed or Duramed’s designee (“Termination Assistance Services”). Duramed shall reimburse
Shire for the reasonable costs of Shire in providing Termination Assistance Services. The rights
of Duramed under this Section 8.1 shall be without prejudice to the Parties’ rights to pursue legal
remedies for breach of this Agreement, either for breaches prior to termination or during the
period this Agreement is continued in force post termination.

     Section 8.2. Development of Changeover Plan. If and to the extent requested by
Duramed, whether prior to, upon, or following termination of this Agreement by Duramed, Shire shall
use commercially reasonable efforts to assist Duramed in developing a plan that shall specify the
tasks to be performed by the Parties in connection with the Termination Assistance Services and the
schedule for the performance of such tasks (a “Changeover Plan”). The Changeover Plan
shall include descriptions of the services, fees, documentation and access requirements that will
promote an orderly transition of the manufacture of Product to Duramed or its designee.

     Section 8.3. Know-How, Infrastructure, and Software. In connection with the
Termination Assistance Services, Shire shall make available to Duramed or its designee, to the
extent owned or controlled by and in the possession of Shire and reasonably required to manufacture
the applicable Product, (i) copies of all applicable requirements, standards, policies, reports and
report formats, user manuals, technical manuals, system architecture, processes, operating
procedures and other documentation, (ii) copies of flow charts of the manufacturing procedures and
work instructions related to manufacturing the relevant Product, (iii) a list of all material
equipment, including the source of such equipment, utilized in the production of the applicable
Product, (iv) copies of all current specifications, including packaging, for the relevant Product,
(v) copies of all standard operating procedures for the manufacturing procedures to be made
available to Duramed, (vi) all necessary environmental conditions necessary to manufacture the
relevant Product and copies of any existing external environmental impact studies based on the
materials or methods employed in the manufacturing method to be made available to Duramed, and
(vii) such other documentation as the Parties may agree.

ARTICLE IX

FORCE MAJEURE

12

 

     Section 9.1. Force Majeure. No Party shall be responsible for failure or delay in
performance hereunder due to reasons beyond its reasonable control, including without limitation,
by reason of fire, flood, riot, freight embargoes, acts of God or of the public enemy, war or civil
disturbances, general shortage of raw materials, or any future laws, rules, regulations or acts of
any government affecting a Party that would delay or prohibit performance hereunder (a “Force
Majeure Event”). Upon the occurrence of a Force Majeure Event, the Party whose performance is
so affected shall promptly give notice to the other Party of the occurrence or circumstance upon
which it intends to rely to excuse its performance. During the duration of the Force Majeure
Event, the Party so affected shall use its reasonable commercial efforts to avoid or remove such
Force Majeure Event and shall take reasonable steps to resume its performance under this Agreement
with the least possible delay. Any Force Majeure Event must be beyond the control and without the
fault or negligence of the Party claiming excusable delay, provided that, breaches by any Party’s
subcontractors shall not excuse any delay or failure by that Party.

ARTICLE X

CONFIDENTIALITY

     Section 10.1. Confidential Information. As used in this Agreement, the term
“Confidential Information” means all secret, confidential or proprietary information or
data, whether provided in written, oral, graphic, video, computer, electronic or other form,
provided pursuant to this Agreement or generated pursuant to this Agreement by one Party or its
Affiliates (the “Disclosing Party”) to the other Party or its Affiliates (the
“Receiving Party”), including but not limited to, information relating to the Disclosing
Party’s existing or proposed research, development efforts, patent applications, business or
products, and any other materials that have not been made available by the Disclosing Party to the
general public. Confidential Information shall not include any information or materials that:

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

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

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

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

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

13

 

     Section 10.2. Confidentiality Obligations. Each of Duramed and Shire shall keep
confidential all Confidential Information of the other Party with the same degree of care it
maintains the confidentiality of its own Confidential Information but in no event less than a
reasonable degree of care. Neither Party shall use such Confidential Information for any purpose
other than in performance of this Agreement or disclose the same to any other Person other than to
such of its and its Affiliates’ directors, managers, employees, independent contractors, agents or
consultants who are bound by confidentiality obligations consistent with those contained herein and
who have a need to know such Confidential Information to implement the terms of this Agreement or
enforce its rights under this Agreement. Upon termination of this Agreement, the Receiving Party
shall return or destroy all documents, tapes or other media containing Confidential Information of
the Disclosing Party that remain in the possession of the Receiving Party and its Affiliates or
their directors, managers, employees, independent contractors, agents or consultants, except that
the Receiving Party may keep one copy of the Confidential Information in the legal department files
of the Receiving Party, solely for archival purposes. Such archival copy shall continue to be
subject to the provisions of this Article X.

     Section 10.3. Permitted Disclosure and Use. Notwithstanding Section 10.2, a Party may
disclose Confidential Information belonging to the other Party only to the extent such disclosure
is reasonably necessary to: (a) obtain Regulatory Approval to the extent such disclosure is made to
a Governmental Authority; (b) comply with or enforce any of the provisions of this Agreement; (c)
comply with Laws; or (d) comply with applicable stock exchange regulations. If a Party deems it
necessary to disclose Confidential Information of the other Party pursuant to this Section 10.3,
such Party shall give reasonable advance notice of such disclosure to the other Party to permit
such other Party sufficient opportunity to object to such disclosure or to take measures to ensure
confidential treatment of such information. In addition, notwithstanding Section 10.2, the Parties
shall cooperate to prepare standardized public responses to anticipated inquiries from the public,
press, stockholders, investors and/or analysts with respect to the activities hereunder. Despite
the foregoing, each Party agrees that the other Party is free to disclose this Agreement in its
entirety to the United States Federal Trade Commission and the United States Department of Justice,
or to any court with jurisdiction over the litigations settled under the Settlement Agreement
between Shire Laboratories Inc. and Barr Laboratories Inc. dated August 14, 2006.

     Section 10.4. Unauthorized Disclosure. The Receiving Party acknowledges and agrees
that the Confidential Information of the Disclosing Party constitutes proprietary information and
trade secrets valuable to the Disclosing Party, and that the unauthorized use, loss or outside
disclosure of such Confidential Information shall be presumed to cause irreparable injury to the
Disclosing Party.

     Section 10.5. Notification. The Receiving Party shall notify the Disclosing Party
promptly upon discovery of any unauthorized use or disclosure of the Disclosing Party’s
Confidential Information, and shall cooperate with the Disclosing Party in any reasonably requested
fashion to assist the Disclosing Party to regain possession of such Confidential Information and to
prevent its further unauthorized use or disclosure. The Receiving Party acknowledges that monetary
damages may not be a sufficient remedy for unauthorized disclosure of Confidential Information and
that the Disclosing Party may be entitled, without

14

 

waiving other rights or remedies, to such injunctive or equitable relief as may be deemed
proper by a court of competent jurisdiction in the event of such unauthorized disclosure.

     Section 10.6. Confidentiality of this Agreement. The terms of this Agreement shall be
Confidential Information of each Party and, as such, shall be subject to the provisions of this
Section 10.6.

ARTICLE XI

INDEMNIFICATION

     Section 11.1. Indemnification by Duramed. Duramed hereby agrees to hold Shire, its
Affiliates, and their respective directors, agents and employees harmless from and against any and
all Losses arising in connection with any and all charges, complaints, actions, suits, proceedings,
hearings, investigations, claims, demands, judgments, orders, decrees, stipulations or injunctions
by a third party (each a “Third Party Claim”) resulting directly from (a) any breach by
Duramed of any of its representations, warranties, covenants or obligations pursuant to this
Agreement, (b) the negligence or willful misconduct by Duramed or its Affiliates or their
respective officers, directors, employees, agents or consultants in performing any obligations
under this Agreement, (c) the Product, including the use, handling, storage, sale or other
disposition of Product (including, without limitation, those Third Party Claims that involve
product defect, product liability, death or bodily injury (or allegations thereof) to any
individual or any property, or (d) infringement of intellectual property based on the Product
Specification, Packaging Specifications, manufacture, use, sale, offer for sale, importation or
other distribution of Product, except to the extent that such Losses in (a) through (d) result from
the negligence or willful misconduct of Shire or it’s third party supplier of Product or breach of
this Agreement by Shire.

     Section 11.2. Indemnification by Shire. Shire hereby agrees to hold Duramed, its
Affiliates, and their respective directors, agents and employees harmless from and against any and
all Losses arising in connection with any and all Third Party Claims resulting directly from (a)
any breach by Shire of any of its representations, warranties, covenants or obligations pursuant to
this Agreement, or (b) the negligence or willful misconduct of Shire or its Affiliates or their
respective officers, directors, employees, agents or consultants in performing any obligations
under this Agreement, or (c) claims that involve product defect, product liability, death or bodily
injury (or allegations thereof) to any individual or any property to the extent that such claim
results from Shire’s breach, negligence or willful misconduct hereunder, or the negligence or
willful misconduct of Shire’s third party supplier of Products, except to the extent that such
Losses in (a) through (c) result from the negligence or willful misconduct of Duramed, or the
breach of this Agreement by Duramed.

     Section 11.3. Notice of Claim. All indemnification claims in respect of any
indemnitee seeking indemnity hereunder (collectively, the “Indemnitees” and each an
“Indemnitee”) shall be made solely by the corresponding Party (the “Indemnified
Party”). The Indemnified Party shall give the indemnifying Party (the “Indemnifying
Party”) prompt written notice (an “Indemnification Claim Notice”) of any Losses or the
discovery of any fact upon which such Indemnified Party intends to base a request for
indemnification hereunder, but in no event shall the Indemnifying Party be liable for any Losses
that result from any delay in providing such notice which materially prejudices the defense of such
Third Party Claim. Each

15

 

Indemnification Claim Notice must contain a description of the claim and the nature and amount
of such Loss (to the extent that the nature and amount of such Loss are known at such time).
Together with the Indemnification Claim Notice, the Indemnified Party shall furnish promptly to the
Indemnifying Party copies of all notices and documents (including court papers) received by any
Indemnitee in connection with the Third Party Claim. The Indemnifying Party shall not be obligated
to indemnify the Indemnified Party to the extent any admission or statement made by the Indemnified
Party materially prejudices the defense of such Third Party Claim.

     Section 11.4. Control of Defense. At its option, the Indemnifying Party may assume
the defense of any Third Party Claim subject to indemnification hereunder by giving written notice
to the Indemnified Party within thirty (30) days after the Indemnifying Party’s receipt of an
Indemnification Claim Notice. Upon assuming the defense of a Third Party Claim, the Indemnifying
Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel it
selects. Should the Indemnifying Party assume the defense of a Third Party Claim, the Indemnifying
Party shall not be liable to the Indemnified Party or any other Indemnitee for any legal expenses
subsequently incurred by such Indemnified Party or other Indemnitee in connection with the
analysis, defense or settlement of the Third Party Claim.

     Section 11.5. Right to Participate in Defense. Without limiting Section 11.4, any
Indemnitee shall be entitled to participate in, but not control, the defense of a Third Party Claim
for which it has sought indemnification hereunder and to employ counsel of its choice for such
purpose; provided, however, that such employment shall be at the Indemnitee’s own expense unless
(a) the employment thereof has been specifically authorized by the Indemnifying Party in writing,
or (b) the Indemnifying Party has failed to assume the defense and employ counsel in accordance
with Section 11.4 (in which case the Indemnified Party shall control the defense).

     Section 11.6. Settlement. With respect to any Losses relating solely to the payment
of money damages in connection with a Third Party Claim and that shall not result in the
Indemnitee’s becoming subject to injunctive or other relief or otherwise adversely affect the
business of the Indemnitee in any manner, and as to which the Indemnifying Party shall have
acknowledged in writing the obligation to indemnify the Indemnitee hereunder, the Indemnifying
Party shall have the sole right to consent to the entry of any judgment, enter into any settlement
or otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its reasonable
discretion, shall deem appropriate (provided, however that such terms shall include a complete and
unconditional release of the Indemnified Party from all liability with respect thereto), and shall
transfer to the Indemnified Party all amounts which said Indemnified Party shall be liable to pay
prior to the time of the entry of judgment. With respect to all other Losses in connection with
Third Party Claims, where the Indemnifying Party has assumed the defense of the Third Party Claim
in accordance with Section 11.4, the Indemnifying Party shall have authority to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of such Loss provided it
obtains the prior written consent of the Indemnified Party (which consent shall be at the
Indemnified Party’s reasonable discretion). The Indemnifying Party that has assumed the defense of
the Third Party Claim in accordance with Section 11.4 shall not be liable for any settlement or
other disposition of a Loss by an Indemnitee that is reached without the written consent of such
Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, no Indemnitee shall admit any liability with respect to, or settle,
compromise or discharge, any Third Party Claim without first offering to the

16

 

Indemnifying Party the opportunity to assume the defense of the Third Party Claim in
accordance with Section 11.4.

     Section 11.7. Cooperation. If the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, the Indemnified Party shall, and shall cause each other Indemnitee to,
cooperate in the defense or prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings,
trials and appeals as may be reasonably requested in connection with such Third Party Claim. Such
cooperation shall include access during normal business hours afforded to the Indemnifying Party
to, and reasonable retention by the Indemnified Party of, records and information that are
reasonably relevant to such Third Party Claim, and making Indemnitees and other employees and
agents available on a mutually convenient basis to provide additional information and explanation
of any material provided hereunder, and the Indemnifying Party shall reimburse the Indemnified
Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation.

     Section 11.8. Expenses of the Indemnified Party. Except as provided above, the
reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred
by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a calendar
quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and subject to refund in the event the
Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

     Section 11.9. Insurance. At all times from the Closing Date until [*] following
termination or expiration of this Agreement, each of Shire and Duramed will maintain product
liability insurance (or self insurance), that is reasonable and customary in the U.S.
pharmaceutical industry for companies of comparable size, but in no event less than [*] per
occurrence and [*] in the aggregate limit of liability per year. Each of Shire and Duramed shall
provide written proof of such insurance or self insurance to the other Party upon request.

     Section 11.10. Exclusion of Certain Damages. IN NO EVENT SHALL ANY PARTY BE LIABLE TO
ANY OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OF ANY KIND
ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, OR FOR ANY DIRECT OR INDIRECT LOSS OF PROFIT,
LOST BUSINESS OPPORTUNITY, LOSS OF OR DISRUPTION TO PRODUCTION OR GOODWILL, EXCEPT TO THE EXTENT
SUCH DAMAGES: (A) ARE INCLUDED IN A THIRD-PARTY CLAIM FOR WHICH SUCH PARTY IS INDEMNIFIED
HEREUNDER; OR (B) ARE FOR BREACH OF CONFIDENTIALITY OBLIGATIONS.

ARTICLE XII

MISCELLANEOUS

     Section 12.1. Entire Agreement; Amendment. This Agreement, together with the Product
Acquisition Agreement, including the exhibits attached hereto and thereto (each of which is hereby
and thereby incorporated herein and therein by reference), set forth the complete, final and
exclusive agreement and all the covenants, promises, agreements, warranties,

17

 

representations, conditions and understandings between the Parties hereto and supersedes and
terminates all prior agreements and understandings between the Parties, which shall continue to
govern the obligations of the Parties with respect to information disclosed thereunder with respect
to periods prior to the Effective Date. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between the Parties other
than as are set forth herein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized
officer of each Party. For the avoidance of doubt, the Parties agree that all covenants, promises,
agreements, warranties, representations, conditions, and understandings set forth herein are made
and deemed effective as of the Effective Date, and that the execution of this Agreement shall not
constitute a waiver of any right or claim of either Party as of the Effective Date.

     Section 12.2. Notices. All notices or other communications that are required or
permitted under this Agreement shall be in writing and delivered personally, sent by facsimile (and
promptly confirmed by personal delivery or overnight courier as provided in this Agreement), or
sent by internationally-recognized overnight courier to the addresses below. Any such
communication shall be deemed to have been given (a) when delivered, if personally delivered or
sent by facsimile on a Business Day (so long as promptly confirmed by personal delivery or
overnight courier as provided in this Agreement), and (b) on the second Business Day after
dispatch, if sent by internationally-recognized overnight courier. Unless otherwise specified in
writing, the mailing addresses of the Parties shall be as described below.

	 	 	 	 	 
	 

	 	For Duramed:
	 	Duramed Laboratories, Inc.
	 

	 	 	 	400 Chestnut Ridge Road
	 

	 	 	 	Woodcliff Lake, NJ 07677
	 

	 	 	 	Phone: 201-930-3300
	 

	 	 	 	Fax: 201-930-3330
	 

	 	 	 	Attention: President
	 
	 	 	 	 
	 

	 	with a copy to:
	 	Barr Pharmaceuticals, Inc.
	 

	 	 	 	400 Chestnut Ridge Road
	 

	 	 	 	Woodcliff Lake, NJ 07677
	 

	 	 	 	Phone: 201-930-3300
	 

	 	 	 	Fax: 888-843-0563
	 

	 	 	 	Attention: General Counsel
	 
	 	 	 	 
	 

	 	For Shire:
	 	Shire LLC
	 

	 	 	 	725 Chesterbrook Boulevard
	 

	 	 	 	Wayne, Pennsylvania 19087-5637
	 

	 	 	 	Fax: (484) 595-8163
	 

	 	 	 	Attention: General Counsel
	 
	 	 	 	 
	 

	 	with a copy to:
	 	Morgan, Lewis & Bockius LLP
	 

	 	 	 	502 Carnegie Center
	 

	 	 	 	Princeton, NJ 08540
	 

	 	 	 	Fax: (609) 919-6701

18

 

	 	 	 	 	 
	 

	 	 	 	Attention: Randall B. Sunberg

     Section 12.3. Independent Contractors. In making and performing this Agreement, Shire
and Duramed shall act at all times as independent contractors and nothing contained in this
Agreement shall be construed or implied for any purpose to create an agency, partnership, limited
partnership, joint venture or employer and employee relationship between Shire and Duramed and this
Agreement shall not be construed to suggest otherwise. At no time shall one Party make commitments
or incur any charges or expenses for or in the name of the other Party. Except as otherwise
provided in this Agreement, each Party shall be solely responsible for its own costs and expenses
associated with this Agreement.

     Section 12.4. Maintenance of Records. Each Party shall keep and maintain all records
required by Law with respect to the Products and shall make copies of such records available to the
other Party upon reasonable request.

     Section 12.5. United States Dollars. References in this Agreement to “Dollars” or “$”
shall mean the legal tender of the United States.

     Section 12.6. No Strict Construction. This Agreement has been prepared jointly and
shall not be strictly construed against either Party.

     Section 12.7. Assignment. Neither Party shall sell, transfer, assign, delegate,
pledge or otherwise dispose of, whether voluntarily, involuntarily, by operation of Law or
otherwise, this Agreement or any of its rights or obligations under this Agreement without the
prior written consent of the other Party (which consent may be granted, withheld or conditioned at
such other Party’s sole and absolute discretion); provided, however, that either Party may assign
or transfer this Agreement or any of its rights or obligations under this Agreement without the
consent of the other Party to any Affiliate of such Party, or to any Third Party (a) with which it
merges or consolidates, or to which it transfers all or substantially all of its assets to which
this Agreement pertains or (b) in part, in connection with the sale or transfer of such Party’s
business relating to Commercialization of a Collaboration Product within a particular country. The
assigning Party (unless it is not the surviving entity) shall remain jointly and severally liable
with, and shall guarantee the performance of, the relevant Affiliate or Third Party assignee under
this Agreement, and the relevant Affiliate assignee, Third Party assignee or surviving entity shall
assume in writing all of the assigning Party’s obligations under this Agreement. Any purported
assignment or transfer in violation of this Section 12.7 shall be void ab initio and of no force or
effect. Notwithstanding anything to the contrary herein or in the Product Acquisition Agreement,
in the event any assignment by Duramed hereunder gives rise to any obligation to withhold any
amounts payable to Shire under this Agreement, Duramed shall pay Shire in full, without regard to
any amounts so withheld, subject to Shire’s obligation to reimburse Duramed upon Shire’s recovery
from the applicable taxing authority of any amounts so withheld. Notwithstanding the foregoing,
Duramed shall be liable for, and indemnify Shire against, any non-U.S. taxes, any value-added or
sales taxes, any duties or levies and assessments, howsoever designated or computed that are
required to be paid or withheld by Duramed on such payments. Duramed shall so indemnify Shire
within forty-five (45) days of Shire’s receipt of notification from Shire (in accordance with
Section 12.2 hereof) that either (i) based upon current facts and circumstances, Shire does not
have or will not have during the applicable tax year any or

19

 

sufficient foreign tax credits available to utilize to offset such tax liability; or (ii)
Shire has applied for a refund from the taxing authority at issue (such notice to include a copy of
such refund application). Notwithstanding anything in this Agreement to the contrary, in the event
that withholding taxes are paid on behalf of Shire by Duramed, if Shire uses a foreign tax credit
received as a result of the payment of withholding taxes by Duramed and thereby reduces the amount
of U.S. income tax that Shire otherwise would have paid, or otherwise receives a refund, Shire
shall refund to Duramed the amount of such reduction with respect to such foreign tax credit or
such refund.

     Section 12.8. Counterparts. This Agreement may be executed in two counterparts, each
of which shall be deemed an original, but all of which together shall constitute one and the same
instrument. Signatures provided by facsimile transmission shall be deemed to be original
signatures.

     Section 12.9. Further Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be reasonably necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

     Section 12.10. Severability. If any one or more of the provisions of this Agreement
is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal
can be or is taken, the provision shall be considered severed from this Agreement and shall not
serve to invalidate any remaining provisions hereof. The Parties shall make a good fait effort to
replace any invalid or unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement may be realized.

     Section 12.11. Headings. The headings for each article and section in this Agreement
have been inserted for convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular article or section.

     Section 12.12. No Waiver. Any delay in enforcing a Party’s rights under this
Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of
such Party’s rights to the future enforcement of its rights under this Agreement, excepting only as
to an express written and signed waiver as to a particular matter for a particular period of time.

[signature page follows]

20

 

     IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be signed by their
respective representatives thereunto duly authorized, all as of the date first written above.

	 	 	 	 	 	 	 
	 	 	SHIRE LLC
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	Name:	 	Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	Title:	 	CEO	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	DURAMED PHARMACEUTICALS, INC.
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ William McKee	 	 
	 

	 	 	 	 	 	 
	 

	 	Name:	 	William McKee	 	 
	 

	 	 	 	 	 	 
	 

	 	Title:	 	Sr. V.P., Chief Financial Officer & Treasurer	 	 
	 

	 	 	 	 	 	 

SHIRE plc, a British public limited company having a principal place of business at Hampshire
International Business Park, Chineham, Basingstoke, England RG24 8EP, hereby guarantees in the
performance of Shire of all obligations of Shire under this Agreement, in accordance with the terms
and conditions of this Agreement, including any applicable notice or cure periods.

SHIRE PLC

	 	 	 	 	 
	By:
	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 
	Name:

	 	Matthew Emmens 	 	 
	 

	 	 	 	 
	Title:
	 	CEO	 	 
	 

	 	 	 	 

[Signature Page to Adderall IR Supply Agreement]

1

 

EXHIBIT A

QUALITY AGREEMENT

2

 

SCHEDULE 1

FORM OF COA

3

 

SCHEDULE 3 – REFERENCE INVENTORY AMOUNTS OF FINISHED GOODS PRODUCT

HELD BY SHIRE AS OF THE DATE HEREOF

	 	 	 
	ADDERALL IR
	DOSAGE	 	# OF BOTTLES OF 100 TABLETS
	[*]

	 	[*]
	[*]

	 	[*]
	[*]

	 	[*]
	[*]

	 	[*]
	[*]

	 	[*]
	[*]

	 	[*]
	[*]

	 	[*]

4

 

EXHIBIT D

GENERAL ASSIGNMENT AND BILL OF SALE

     THIS GENERAL ASSIGNMENT AND BILL OF SALE (this “General Assignment”), dated as of
September 29, 2006, is made and entered into by and between Shire LLC, a Kentucky limited liability
company (“Shire”), and Duramed Pharmaceuticals, Inc., a Delaware corporation (“Duramed”). All
capitalized words and terms used in this General Assignment and not defined herein shall have the
respective meanings ascribed to them in the Product Acquisition and License Agreement, dated as of
August 14, 2006 (the “Agreement”).

     WHEREAS, Shire and Duramed have entered into the Agreement pursuant to which Shire, among
other things, desires to sell, transfer, convey and license to Duramed Shire’s right, title and
interest in and to certain rights to the Product and the Purchased Assets, and Duramed wishes to
assume certain liabilities relating to the Product; and

     WHEREAS, in performance of their respective obligations under the Agreement, Shire and Duramed
desire to execute and deliver this General Assignment.

     NOW, THEREFORE, for and in consideration of the Purchase Price and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as
follows:

     1. Shire does hereby sell, assign, convey and transfer unto Duramed the Purchased Assets.
Duramed and its successors and assigns are to have and to hold all of such Purchased Assets unto
Duramed and its successors and assigns forever.

     2. This General Assignment shall inure to the benefit of, and be binding upon, the parties
hereto and their respective heirs, successors, trustees, transferees and permitted assigns.

     3. Each of the parties agrees that it will, from time to time after the date hereof, without
further consideration, execute, acknowledge and deliver all such further acts, assignments,
transfers, conveyances, evidences of title, assumptions and assurances as may be required to carry
out the intent of this General Assignment and to sell, assign, convey, transfer and deliver the
Purchased Assets to Duramed.

     4. This General Assignment is made in accordance with, and is subject to, all of the terms and
conditions set forth in the Agreement. Except as otherwise expressly set forth herein, the terms
and conditions of the Agreement shall control the terms and conditions of this General Assignment.

     5. This General Assignment may be executed in two counterparts, each of which shall be deemed
an original, but both of which together shall constitute one and the same instrument. This General
Assignment may be executed by facsimile signatures, which signatures shall have the same force and
effect as original signatures.

 

 

     IN WITNESS WHEREOF, the parties hereto have executed this General Assignment and Assumption as
of the date first above written.

	 	 	 	 	 	 	 
	 	 	SHIRE LLC
	 
	 	 	 	 	 	 
	 

	 	By:	 	/s/ Matthew Emmens	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	Name: Matthew Emmens	 	 
	 

	 	 	 	Title:   CEO	 	 
	 
	 	 	 	 	 	 
	 	 	DURAMED PHARMACEUTICALS, INC.
	 
	 	 	 	 	 	 
	 

	 	By:	 	 /s/ Fred Wilkinson	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	Name: Fred Wilkinson	 	
	 

	 	 	 	Title:   President & C.O.O.	 	 

 

 

EXHIBIT E

Form of FDA Letter

[DATE]

Thomas Laughren, MD

Director, Division of Psychiatry Products

Office of Drug Evaluation I

Centre for Drug Evaluation and Research

Document Control Room

Food and Drug Administration

5901-B Ammendale Road

Beltsville, MD 20705-1266

ARTICLE 1 NDA 11-522

ADDERALL (MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT)

TABLETS

ARTICLE 2 CHANGE IN OWNERSHIP OF AN APPLICATION

Reference is made to NDA 11-522 for Adderall Tablets; and to 21 CFR § 314.72 pertaining to a change
in ownership of an application.

This is to notify the agency that Duramed Pharmaceuticals, Inc., (“Duramed”), a subsidiary of Barr
Pharmaceuticals, Inc, is the regulatory agent for Duramed Pharmaceuticals, Inc. In accordance with
provisions of §314.72, we are submitting an application form signed by the new owner along with the
following information:

	 	1.	 	Duramed commits to the agreements, promises, and conditions made by Shire, the former
owner of NDA 11-522, and contained in the application;
	 
	 	2.	 	The change in ownership is effective [DATE]; and
	 
	 	3.	 	Duramed has a complete copy of the approved application, including supplements and
records that are to be kept under 21 CFR § 314.81

All future correspondence regarding NDA 11-522 should be directed to:

 

 

Joseph A. Carrado, M.Sc., R.Ph.

Vice President, Clinical Regulatory Affairs

Duramed Research, Inc.

One Belmont Avenue, 11th Floor

Bala Cynwyd, PA 19004

Phone (610) 747 2910

Fax: (610) 747 6607

Also, please find attached a copy of Shire’s Transfer of Ownership letter, dated [DATE], for the
Division’s convenience.

If you have any questions or require any additional information, please contact the undersigned at
(610) 747-2910.

Sincerely,

Joseph A. Carrado, M.S.c., R.Ph.

Vice President

Clinical Regulatory Affairs

 

 

EXHIBIT F

Form of Correspondence to Third Parties 

 

 

SCHEDULE 1.18

Licensed Patents

[*]

 

 

SCHEDULE 1.31

Product Trademark

	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Serial No./	 	Reg. No./
	Mark	 	Owner	 	Country	 	Goods/Services	 	Filing Date	 	Reg. Date
	[*]

	 	[*]
	 	[*]
	 	[*]
	 	[*]
	 	[*]

 

 

SCHEDULE 2.8

Allocation of Purchase Price

 

 

SCHEDULE 4.1

Shire Disclosure Schedule

 

 

SCHEDULE 4.1(h)

Litigation

1. Branson v. Shire Richwood Inc.

     Filed on October 3, 2002 in the Circuit Court, Boone County, Kentucky, plaintiff, claims that
an alleged psychotic episode leading to the death of her child was caused by the her ingestion of
Adderall. The Court filed the Judgment on April 17, 2006 and plaintiff failed to file a notice of
appeal of the jury’s defense verdict by the deadline to appeal, May 17, 2006.

2. [*]

3. UZammit v. Shire US Inc.

     Pio Peter Zammit, the plaintiff, claims that his ingestion of 20mg of Adderall caused him to
suffer a heart attack on April 24, 2002. Plaintiff claims negligence and failure to warn strict
products liability for failing to adequately warn of the risks of heart attack while taking
Adderall. Plaintiff is currently appealing the District Court’s dismissal of the case to the Sixth
Circuit. Shire has filed a motion to dismiss plaintiff’s appeal.

4. [*]

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