PRODUCT DEVELOPMENT AND LICENSE AGREEMENT

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

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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

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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.

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      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”

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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

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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:

 

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      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.

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      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.

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                (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.

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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.

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           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

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

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      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.

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

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

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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 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

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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.

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

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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 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

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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 [*].

                (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

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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.

      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

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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 or