OPTION AND LICENSE AGREEMENT

Exhibit 10.4

EXECUTION COPY

OPTION AND LICENSE AGREEMENT

This OPTION AND LICENSE AGREEMENT (this “ Agreement ”), dated as of March 24, 2004 (the “ Effective Date ”), is made by and between Barr Laboratories, Inc., a corporation organized and existing under the laws of Delaware (“ Barr ”), and Galen (Chemicals) Limited, a company organized and existing under the laws of the Republic of Ireland (“ Galen ”). Barr and Galen are each sometimes referred to individually as a “ Party ” and together as the “ Parties .”

RECITALS

WHEREAS, Barr and Galen are pharmaceutical companies engaged in the marketing and sale of pharmaceutical products, including women’s health products; and

WHEREAS, Barr owns or controls certain product registrations (or applications therefor) and know-how related to the Licensed Products (as defined below); and

WHEREAS, Galen desires to obtain from Barr, and Barr desires to grant to Galen, an option to acquire, and upon exercise of such option a license to, certain exclusive and nonexclusive rights under the Approved ANDAs (as defined below) to commercialize the Licensed Products in the Territory (as defined below), upon the terms and subject to the conditions of this Agreement; and

WHEREAS, in the event that Galen exercises the option, Barr desires to supply to Galen, and Galen desires to obtain exclusively from Barr, all of Galen’s requirements of Licensed Product for the Territory, upon the terms and subject to the conditions of the Supply Agreement (defined below);

NOW, THEREFORE, in consideration of the foregoing premises and the representations, covenants and agreements contained herein, the Parties, intending to be legally bound, hereby agree as follows:

ARTICLE 1

DEFINITIONS

When used in this Agreement, whether in the singular or plural, each of the following capitalized terms shall have the meanings set forth in this Article 1:

1.1 “ 21-Day ANDA ” means the Abbreviated New Drug Application number 76-198, which references the product approved under New Drug Application 18-127, filed with the FDA by Barr in order to obtain approval to commence sale of the 21-Day Licensed Product (and any supplement or amendment filed pursuant to FDA requirements).

1.2 “ 28-Day ANDA ” means the Abbreviated New Drug Application number 76-238, which references the product approved under New Drug Application 17-716, filed with the FDA by Barr in order to obtain approval to commence sale of the 28-Day Licensed Product (and any supplement or amendment filed pursuant to FDA requirements).

1.3 “ 21-Day Licensed Product ” means 0.4 mg. norethindrone/.035 mg. ethinyl estradiol 21-day oral tablet, described in, and the sale of which is or will be permitted in the Territory by, the 21-Day ANDA (to the extent the 21-Day ANDA is or becomes an Approved ANDA).

1.4 “ 28-Day Licensed Product ” means 0.4 mg. norethindrone/.035 mg. ethinyl estradiol 28-day oral tablet, described in, and the sale of which is or will be permitted in the Territory by, the 28-Day ANDA (to the extent the 28-Day ANDA is or becomes an Approved ANDA).

1.5 “ Affiliates ” means, with respect to a Party, any Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such Party at any time during the period for which the determination of affiliation is being made. For the purposes of this definition, “ control ” (including the terms “ controlled by ” and “ under common control with ”) means the possession, directly or indirectly, of the power to direct or cause the direction of the management, policies or affairs of a Person, whether through ownership of voting securities or general partnership or managing member interests, by contract or otherwise, including the ownership, directly or indirectly, of securities having the power to elect a majority of the board of directors or similar body governing the affairs of such Person. Without limiting the generality of the foregoing, a Person shall be deemed to control any other Person in which it owns, directly or indirectly, a majority of the voting interests.

1.6 “ ANDAs ” means collectively or either, as the case may be, the 21-Day ANDA and the 28-Day ANDA.

1.7 “ Applicable Law ” means all applicable laws, statutes, ordinances, rules, regulations (including cGMPs (defined below)), writs, judgments, decrees, injunctions (whether preliminary or final), orders and other requirements (including Abbreviated New Drug Applications, permits, certificates and other product authorizations and approvals) of any Governmental Authority (including the FTC and FDA or any self-regulatory organization or stock exchange).

1.8 “A pproved ANDA ” means any of the ANDAs that has been approved by the FDA.

1.9 “ Business Day ” means any day other than a Saturday, Sunday or day on which banks in New York, New York are authorized or obligated by Applicable Law to close. Any reference in this Agreement to “day” whether or not capitalized shall refer to a calendar day, not a Business Day.

1.10 “ cGMPs ” means current Good Manufacturing Practices (as set forth in C.F.R. Parts 210 and 211)

1.11 “ CMC Section ” means the Chemistry, Manufacturing and Controls Section of a regulatory submission document included in an ANDA as set forth in 21 C.F.R. §314.94(a)(9).

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1.12 “ Damages ” means any and all costs, losses, claims, liabilities, fines, penalties, awards, verdicts, settlements, judgments, interests and expenses, including reasonable attorney’s fees and costs of suit.

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

1.14 “ FTC ” means the United States Federal Trade Commission, or any successor agency thereof.

1.15 “ Force Majeure ” means any occurrence beyond the reasonable control of a Party that prevents or substantially interferes with the performance by the Party of any of its obligations hereunder, if such occurs by reason of any act of God, flood, fire, explosion, earthquake, strike, lockout, labor dispute, casualty, accident, war, revolution, civil disorder, terrorist attack, embargo, any restriction of any Governmental Authority (to the extent such Governmental Authority has ruling authority over such Party), or other similar event beyond the reasonable control of such Party, if and only if the Party affected shall have used commercially reasonable efforts to avoid such occurrence.

1.16 “ Governmental Authority ” means any governmental, regulatory or administrative authority, court, tribunal, arbitrator, agency, commission, official or other instrumentality of any supranational authority or any federal, state, provincial, municipal, county, city or other political subdivisions thereof.

1.17 “ HSR Act ” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, Section 7A of the Clayton Act, 15 USC §18A, as amended.

1.18 “ Know-How ” means any technical information (whether patented, patentable or otherwise), including all product specifications, processes, product designs, plans, trade secrets, ideas, concepts, manufacturing, engineering and other manuals and drawings, standard operating procedures, flow diagrams, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, safety, efficacy, stability, quality assurance, quality control and clinical data, data, research records, compositions, annual product reviews, process validation reports, analytical method validation reports, specifications for stability trending and process controls, testing and reference standards for impurities in and degradation of products, technical data packages, chemical and physical characterizations, dissolution test methods and results, formulations for administration, clinical trial reports, regulatory communications and labeling and all other confidential or proprietary technical and business information, relating to the Licensed Products, whether written or oral and in whatever format kept.

1.19 “ Licensed Products ” means the 21-Day Licensed Product and the 28-Day Licensed Product.

1.20 “ NDC ” means the “National Drug Code” identifying number for a Licensed Product maintained by the FDA, which is an 11-digit number comprised of the labeler code (which is assigned by the FDA and identifies the establishment/manufacturer), product (which identifies the specific product or formulation), and package size code.

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1.21 “ Person ” or “ person ” means any individual, firm, corporation, partnership, limited liability company, trust, joint venture, Governmental Authority, or other entity or organization.

1.22 “ Promotional Materials ” means Galen’s promotional and advertising materials and programs relating to Finished Product sold under the Ovcon ^® trademark.

1.23 “ Supply Agreement ” means the Finished Product Supply Agreement attached hereto as Exhibit A , dated as of the date hereof and effective in accordance with the terms set forth therein.

1.24 “ Term ” means the Option Term and the License Term, as the same may be earlier terminated in accordance with this Agreement.

1.25 “ Territory ” means the United States and its states, territories and possessions, including the Commonwealth of Puerto Rico and the District of Columbia.

1.26 “ Third Party ” means any Person other than Barr, Galen and their respective Affiliates.

ARTICLE 2

OPTION

2.1 Grant of Option . Barr hereby grants to Galen, and Galen accepts from Barr, an exclusive, non-transferable (except as set forth in Section 3.2 and/or Section 9.6), irrevocable option (the “ Option ”) to acquire the licenses set forth in Section 3.1 (collectively, the “ Licenses ”), upon exercise in the manner described in Section 2.5. Barr shall not execute any agreements (including an agreement in principle or an option, contingent or future agreement) with an Affiliate or Third Party to exercise, or may not itself exercise, any rights in conflict with Galen’s rights in this Article 2. Barr may not sell, transfer or license the Approved ANDAs during the First License Term without Galen’s prior written consent, which shall not be unreasonably withheld, conditioned or delayed; provided , that Barr may sell, transfer or license the Approved ANDAs during the First License Term without such consent (a) to any Affiliate of Barr, provided, no such assignment shall relieve Barr of its obligations hereunder, or (b) in connection with a merger, reorganization, change of control, or sale of all or substantially all of Barr’s business to which this Agreement relates; provided, further , that, notwithstanding anything in this Section 2.1 to the contrary, any permitted sale, transfer or license of the Approved ANDAs hereunder shall be expressly subject to Galen’s rights hereunder and any such transferee shall expressly agree to assume Barr’s obligations hereunder.

2.2 Payment for Option . On the Effective Date, Galen shall pay to Barr the non-refundable sum of One Million U.S. Dollars ($1,000,000) in immediately available funds by wire transfer to the credit of such bank account as designated by Barr in Schedule 2.2 .

2.3 Deliveries on the Effective Date .

(a) On the Effective Date, Galen will deliver or cause to be delivered to Barr:

(i) a duly executed Supply Agreement;

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(ii) a guarantee, duly executed by Galen Holdings PLC, in the form attached hereto as Exhibit B ; and

(iii) any other agreements or documents reasonably necessary to consummate the transactions contemplated hereby, in form and substance reasonably satisfactory to Barr.

(b) On the Effective Date, Barr will deliver or cause to be delivered to Galen:

(i) a duly executed Supply Agreement;

(ii) a guarantee, duly executed by Barr Pharmaceuticals, Inc., in the form attached hereto as Exhibit C ; and

(iii) any other agreements or documents reasonably necessary to consummate the transactions contemplated hereby, in form and substance reasonably satisfactory to Galen.

2.4 Option Term . The Option may be exercised at any time during the period (such period, the “ Option Term ”) commencing on the date that Galen receives notification from Barr that Barr has received the first notice from the FDA that an ANDA has become an Approved ANDA, and ending at 11:59 P.M., Eastern Standard Time on the forty-fifth (45 ^th ) day thereafter. Barr shall notify Galen in writing of its receipt of such notifications and as to the commencement of the Option Term as provided herein within three (3) Business Days following such receipt.

2.5 Exercise of Option . To exercise the Option, Galen shall deliver to Barr during the Option Term (a) a written notice, given in accordance with Section 9.5, indicating Galen’s election to exercise the Option and acquire the Licenses subject to the terms and conditions of this Agreement (the “ Exercise Notice ”) and (b) the Exercise Payment, in accordance with Section 2.6 (the date on which Barr has received all of the foregoing, the “ Exercise Date ”). For avoidance of doubt, notwithstanding that only one of the ANDAs becomes an Approved ANDA during the Option Term, the exercise of the Option shall be as to both ANDAs and the Licenses will be effective as to the second ANDA (and the Licensed Product related thereto) if and when such second ANDA shall become an Approved ANDA, immediately upon Barr’s receipt of written notice of such approval and without further action by either Party. Barr shall promptly notify Galen in writing as to Barr’s receipt of such second approval.

2.6 Events Upon Exercise .

(a) On or before the Exercise Date, Galen shall pay to Barr the non-refundable sum of Nineteen Million U.S. Dollars ($19,000,000) in immediately available funds by wire transfer to the credit of such bank account as designated by Barr in Schedule 2.2 (the “ Exercise Payment ”) in respect of the Licenses granted herein.

(b) On the Exercise Date, (i) the Licenses shall be deemed immediately granted as of such date and fully-paid and (ii) the Supply Agreement shall become effective.

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ARTICLE 3

LICENSES

3.1 License Grant .

(a) Subject to the exercise of the Option and the other terms and conditions herein, Barr hereby grants to Galen an exclusive (including with respect to Barr and its Affiliates), fully-paid license under each Approved ANDA solely for the purposes of (i) marketing, having marketed, using, having used, commercializing, have commercialized, distributing, having distributed, offering for sale, selling and having sold the Licensed Products in the Territory and (ii) importing or exporting, or having imported or exported the Licensed Products solely for the purposes of clause (i), for a period commencing on the Exercise Date and ending at 11:59 p.m., Eastern Time, on the fifth (5th) anniversary thereof (the “ First License Term ”).

(b) At Galen’s election, the First License Term may be renewed on a non-exclusive basis, for a period commencing on the day immediately following the expiration of the First License Term and ending on the fifth (5th) anniversary of the date such period began (the “ Second License Term ” and together with the First License Term, the “ License Term ”), by written notice given to Barr at least six (6) months prior to the expiration of the First License Term.

(c) For purposes of clarity, the foregoing license does not grant to Galen or its sublicensees any right (i) to market, have marketed, commercialize, have commercialized, offer for sale, sell or have sold a Licensed Product outside of the Territory or (ii) to make or have made a Licensed Product anywhere in the world, except through Barr pursuant to, or as contemplated by Section 11.3, Schedule 11.3 and Section 12.3 of, the Supply Agreement.

3.2 Sublicenses and Subcontracting . Notwithstanding anything herein to the contrary, including Section 9.6, Galen may grant sublicenses in order to exercise its rights and carry out its obligations under this Agreement: (a) to its Affiliates, without the prior written consent of Barr; and (b) to third Persons, with Barr’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed. Galen acknowledges that the grant of a sublicense or use of a subcontractor shall not relieve Galen from, and Galen shall remain responsible for, all of its obligations under this Agreement. Galen shall be responsible for the compliance of its Affiliates, sublicensees and subcontractors (other than Barr) with this Agreement.

3.3 Exclusivity . During the First License Term, except as provided in the Supply Agreement, neither Barr nor its Affiliates shall, either itself or with or through a Third Party, (a) market, commercialize, distribute or sell a Licensed Product in the Territory or (b) import or export a Licensed Product for the purposes of clause (a).

3.4 No Implied Licenses . Only the licenses expressly granted herein shall be of legal force and effect. No license rights shall be created hereunder by implication, estoppel or otherwise.

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3.5 Reservation of Rights .

(a) All rights not expressly granted to Galen hereunder are expressly reserved to Barr. Without limiting the foregoing, Barr may, at its discretion, (i) research, have researched, develop, have developed, make or have made, or, subject to Section 3.3, use or have used Licensed Products anywhere in the world at any time, (ii) (A) market, have marketed, commercialize, have commercialized, distribute, have distributed, offer for sale, sell and have sold Licensed Products outside the Territory at any time or (B) import or export, and have imported or exported Licensed products for the purposes of clause (A), and (iii) market, have marketed, commercialize, have commercialized, distribute, have distributed, offer for sale, sell and have sold, import or export, and have imported or exported Licensed Products within or outside the Territory after the expiration of the First License Term.

(b) Barr shall use its commercially reasonable efforts to ensure that Licensed Products (or their ex-Territorial equivalents) sold by it or on its behalf outside the Territory are not transferred to or resold in the Territory, except by Galen. In the event Barr learns of any such activities, it shall cease sales of such products to the offending third party until adequate controls are instituted to arrest such offending sales. Galen shall use its commercially reasonable efforts to ensure that Licensed Products sold by it or on its behalf within the Territory are not transferred to or resold outside the Territory, except by Barr. In the event Galen learns of any such activities, it shall cease sales of such Licensed Products to the offending third party until adequate controls are instituted to arrest such offending sales.

(c) As between the Parties, Barr shall retain ownership of all rights, title and interest in and to the ANDAs, subject to the licenses granted hereunder. Galen shall not contest such ownership or the validity of the ANDAs with respect to the Licensed Products, including in any Proceeding.

3.6 Inventions . As between the Parties, each Party shall be the sole and exclusive owner of any Know-How that it (or an Affiliate or Third Party on its behalf) invents, develops, discovers or creates after the Effective Date (“ Inventions ”). Nothing herein shall obligate either Party to invent, develop, discover or create any Inventions or to file, prosecute, defend or maintain any applications, registrations or patents relating to any of its Inventions. No Inventions of a Party will be made available to the other Party or deemed licensed to the other Party hereunder.

ARTICLE 4

REGULATORY MATTERS

4.1 Responsibility for the ANDAs .

(a) Barr shall maintain the ANDAs in compliance with all material requirements under Applicable Law. Where Barr may lawfully do so, Barr will provide Galen, upon written request after reasonable notice from Galen, with access to copies of all filings submitted by Barr to the FDA in respect of either of the ANDAs. Upon the reasonable request of Barr during the Term, Galen shall as promptly as practicable provide to Barr all such information in its possession or control relating to any Licensed Product as may be reasonably required for the

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foregoing regulatory activities, including sales distribution information relating to the Licensed Products, and otherwise shall provide reasonable assistance to Barr in (i) complying with all Applicable Law and other regulatory obligations in the Territory, including safety updates, amendments, annual reports, pharmacovigilance filings, investigator notifications, manufacturing facility inspections and certifications and product approvals and (ii) preparing the CMC Section of the ANDAs adequate to meet FDA standards with respect to CMC requirements. Neither Party shall at any time knowingly do, cause to be done, or omit or permit any act inconsistent with any such ANDAs.

(b) (i) Except as otherwise expressly provided in this Section 4.1, Barr shall be solely responsible for paying all costs and expenses in connection with managing and maintaining the ANDAs; (ii) Barr shall keep Galen informed on a timely basis as to any developments in respect of the ANDAs that would affect Galen, including all notices received from any Governmental Authority in connection with the ANDAs that would affect Galen; and (iii) Barr shall have the final decision-making authority in every matter in connection with the ANDAs and on whether and how to communicate with Governmental Authorities in connection therewith; provided that (x) Barr will not, except where required by Applicable Law or Governmental Authority, as required or permitted under this Agreement, or as consented to in writing by Galen from time to time, supplement, amend or otherwise alter either of the ANDAs so as to materially and adversely affect the rights granted to Galen hereunder, (y) Barr shall provide Galen with copies of all material correspondence to and from the FDA or other Governmental Authorities in the Territory, and (z) Barr will consult with Galen before taking any action in connection with either of the ANDAs that would adversely affect Galen (including any Recall of Licensed Products as contemplated by Section 4.4) and consider in good faith Galen’s position; provided that Barr shall have final decision-making authority as contemplated in clause (iii) above.

(c) In the event Barr materially breaches any of the provisions of this Section 4.1, notwithstanding anything herein to the contrary, in addition to any other rights and remedies to which Galen may be entitled, Galen may elect not to terminate this Agreement pursuant to Section 8.2(b), and instead to require Barr to appoint Galen as its exclusive agent with respect to all approvals and filings in the Territory in connection with the Licensed Products, and, accordingly, to promptly take all steps necessary to effect the foregoing appointment, including writing a letter to the appropriate Governmental Authorities in the Territory. In such event, as Barr’s agent, Galen shall, except as prohibited by Applicable Law, be the lead regulatory party in the Territory, and the rights and obligations of each Party under Sections 4.1, 4.4, 4.5, 4.6 and 4.7 shall, as appropriate, become the rights and obligations of the other Party; provided , that the rights provided by 4.1(b)(iii) shall remain vested in Barr, as the ANDA holder.

(d) Except as required by Applicable Law, as may be authorized by Barr from time to time or pursuant to clause (c) above, and subject to clause b(iii) above, during the Term, Galen shall not communicate directly with the FDA or any other Governmental Authority in the Territory relating to the ANDAs without the prior written consent of Barr, such consent not to be unreasonably withheld, conditioned or delayed. In furtherance thereof, Galen shall as promptly as practicable refer all FDA communications received by Galen during the Term relating to any Licensed Product to Barr.

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(e) Barr shall not be liable to Galen for Losses incurred by Galen as a direct or indirect result of Galen’s failure to provide information under this Section 4.1.

(f) Barr or its relevant Affiliate may, without the consent of Galen, use or cross-reference the Approved ANDAs in connection with (i) manufacturing Licensed Products under the Supply Agreement or (ii) manufacturing anywhere in the world of any Licensed Product for the marketing, distribution or sale of such product outside the Territory.

4.2 Promotional Materials . Galen shall be solely responsible for ensuring that all Promotional Materials comply with the applicable labeling and ANDAs for a given Licensed Product and with Applicable Law. Notwithstanding Section 4.1(d), Galen shall be solely responsible for submitting all Promotional Materials to the FDA for review and for negotiating with the FDA for approvals of such Promotional Materials; provided that Barr has submitted to the FDA such authorization as may be required by Applicable Law for Galen to submit such Promotional Materials (which Barr will use its commercially reasonable efforts to effect as promptly as reasonably practicable after the Exercise Date; and until such time as such authorizations have been effected, Barr shall use its commercially reasonable efforts to submit all Promotional Materials as required hereunder on behalf of Galen).

4.3 Regulatory Matters Outside the Territory . In the event that a Governmental Authority outside of the Territory in a country where Barr is developing Licensed Products (or, for all purposes of this Section 4.3, their extra-Territorial equivalents) requests that Barr provide it with information within Galen’s possession and such information is not otherwise in Barr’s possession, upon Barr’s reasonable request, Galen will as promptly as practicable make available to Barr such tangible written information in Galen’s possession and control that is requested by such Governmental Authority. Notwithstanding the foregoing, Galen may instead agree, in its sole discretion, to provide such information directly to the applicable Governmental Authority, as the case may be, or to an independent Third Party of its choosing, and shall respond directly (or through its independent agent) to any questions or inquiries from such Governmental Authority regarding the information. In addition, Galen shall have no duty to disclose any of its proprietary or confidential information to any Governmental Authority or any other party, unless the Governmental Authority in question provides for the protection of such proprietary or confidential information from disclosure in a manner substantially similar to that provided by the FDA, and Barr shall provide such cooperation reasonably requested by Galen to assist Galen in receiving such protection. Barr shall reimburse Galen for the out-of-pocket costs and expenses incurred by Galen in complying with any such requests. Galen shall endeavor in good faith to cooperate and comply with any requests from Barr or from any Governmental Authority pursuant to this Section 4.3.

4.4 Recalls .

(a) In the event that either Party obtains information that a Licensed Product or any portion thereof should be alleged or proven not to meet the specifications, labeling, or Approved ANDA for such Licensed Product or to be otherwise defective in the Territory, such Party shall notify the other Party immediately and both Parties shall cooperate fully regarding the investigation and disposition of any such matter, including with respect to any Licensed Product recall, Licensed Product withdrawal or filed correction, as appropriate (collectively, a “ Recall ”).

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Barr and Galen shall each maintain such traceability records as are sufficient and as may be necessary to permit a Recall or field correction of any Licensed Products. In the event (i) any applicable Governmental Authority should issue a request, directive or order that a Licensed Product be Recalled or (ii) either Party determines that any Licensed Product already in interstate commerce in the Territory presents a risk of injury or gross deception or is otherwise defective and that a Recall of such Licensed Product is appropriate, each Party shall give telephonic notice (to be confirmed in writing) to the other within 24 hours of the occurrence of such event.

(b) During (i) the First License Term and (ii) the Second License Term for so long as Galen is the only Person commercializing Licensed Products, Galen shall consult with Barr, but Galen shall have sole responsibility, in its reasonable discretion (but subject to the superseding rights of Barr as the ANDA holder to have the final say pursuant to Section 4.1), for determining all corrective action to be taken (including a Recall) and for carrying out the Recall, if any, which shall be conducted in its own name. Barr will provide reasonable cooperation and assistance to Galen upon request in connection therewith. Barr shall be responsible for all costs and expenses of any such Recall (including any reasonable out-of-pocket costs incurred by Galen in connection with such cooperation) where Barr supplied such product under the Supply Agreement, except to the extent such Recall is attributable to Galen’s (or its designees’, subcontractors’ or Affiliates’) breach of their respective obligations or representations or warranties under this Agreement or the Supply Agreement. Where Galen has elected to assume the manufacturing of the Licensed Product under Section 11.3 of the Supply Agreement and the product subject to such Recall is manufactured by Galen, Galen shall be responsible for all costs and expenses of any such Recall (including any reasonable out-of-pocket costs incurred by Barr in connection with any cooperation it provides hereunder). Commencing during the Second License Term on the date, if any, that Galen is not the only Person commercializing Licensed Products, Barr shall have sole responsibility, in its reasonable discretion, for determining all corrective action to be taken (including a Recall) and for carrying out the Recall, if any, which shall be conducted in its own name. Galen will provide reasonable cooperation and assistance to Barr upon request in connection therewith. Barr shall be responsible for all costs and expenses of any such Recall (including any reasonable out-of-pocket costs incurred by Galen in connection with such cooperation), except to the extent such Recall is attributable to Galen’s (or its designees’, subcontractors’ or Affiliates’) breach of their respective obligations or representations or warranties under this Agreement or the Supply Agreement.

4.5 Adverse Experience . For so long as there is unexpired Licensed Product manufactured under an Approved ANDA in Galen’s inventory, at its wholesalers or their retailers, each Party shall promptly notify the other Party of any