COLLABORATION AND LICENSE AGREEMENT

EXHIBIT 2.3

CONFIDENTIAL MATERIAL OMITTED AND
FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.

Collaboration and License Agreement

     This agreement (“ Agreement ”) is made and entered into as of November 6, 2005 (the “ Execution Date ”), by and between Jerini US, Inc. , a Delaware corporation (“ Jerini ”), and Kos Life Sciences, Inc. , a Delaware corporation (“ Kos ”). Jerini and Kos each may be referred to herein individually as a “ Party ,” or collectively as the “ Parties .”

Recitals

      A.  Jerini and its Affiliates Control certain patents and other intellectual property pertaining to the use of the peptide Icatibant for pharmaceutical applications.

      B.  Jerini and its Affiliates are developing Icatibant for the treatment of angioedema in humans and intend to study and to apply for registration for (among other indications) the treatment of one or more of hereditary angioedema, drug-induced angioedema, pediatric angioedema and idiopathic angioedema.

      C.  Jerini and its Affiliates and their licensor, Sanofi-Aventis, have demonstrated in clinical studies the potential utility of Icatibant for the treatment of resistant ascites in liver disease and for the treatment in asthma.

      D.  The Parties desire to enter into a collaboration under which Jerini and its Affiliates will develop pharmaceutical products containing Icatibant for the treatment of hereditary and other forms of angioedema, and Kos and its Affiliates will develop pharmaceutical products containing Icatibant for the treatment of resistant ascites in liver disease and asthma.

      E.  The Parties further desire to commercialize in the United States and Canada pharmaceutical products containing Icatibant, including by each supporting the promotional activities of the sales force of Kos and its Affiliates and other activities.

     In consideration of the foregoing premises, the mutual promises and covenants set forth in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Jerini and Kos hereby agree as follows:

Agreement

1. Definitions

     When used in this Agreement, capitalized terms will have the meanings as defined below and throughout the Agreement.

      1.1 “ Additional Formulation Product ” means a Licensed Product * * * that has received Marketing Approval in the Territory.

      1.2 “ Affiliate ” means a legal entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with an entity. For purposes of this definition only, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means (a) the possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities or by contract relating to voting rights

or corporate governance, or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a legal entity; provided , that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests. Notwithstanding the foregoing, for the purposes of this Agreement, none of the following persons shall be considered to be an “Affiliate” of Kos or any of Kos’s Affiliates: (i) Michael Jaharis or the spouse or any sibling or lineal descendent of Michael Jaharis or their estates, (ii) any trust for the benefit of Michael Jaharis or the spouse or any sibling or lineal descendent of Michael Jaharis, or (iii) any corporation, limited liability company, partnership, limited partnership, or other entity that is beneficially owned or controlled by any of the persons in clauses (i) or (ii) above, other than Kos Pharmaceuticals, Inc. and its direct and indirect subsidiaries.

      1.3 “ Angioedema Field ” means the treatment of any form of angioedema in humans, including hereditary angioedema, drug-induced angioedema, pediatric angioedema and idiopathic angioedema.

      1.4 “ Assigned Invention ” means: (i) any invention, discovery or Know-How that relates to Icatibant or any Licensed Product and that is conceived, made or generated jointly by both Parties or their respective Affiliates, agents, Sublicensees, or independent contractors (to the extent Controlled by such Party) during the Term, and (ii) any invention, discovery or Know-How that relates solely to Icatibant or Licensed Product and that is conceived, made or generated by Kos, solely or jointly with its Affiliates, agents, Sublicensees or independent contractors (to the extent Controlled by Kos) during the Term.

      1.5 “ Asthma Field ” means the treatment of any form of asthma.

      1.6 “ Aventis Agreement ” means that certain License Agreement between Jerini AG and Aventis Pharma Deutschland GmbH, dated as of November 1, 2001, as amended, under which Jerini has received an exclusive license to certain of the Licensed Technology.

      1.7 “ Bachem Manufacturing Agreement ” means that certain Contract Manufacturing Agreement dated January 28, 2004 by and between Bachem AG and Jerini AG.

      1.8 “ Blocking Patent ” means any issued Patent within Third Party Technology that would be infringed or misappropriated by the manufacture, use or sale in the Licensed Field in the Territory of a Licensed Product developed by Jerini as of the Effective Date.

      1.9 “ Business Day ” means any day other than (i) Saturday or Sunday or (ii) any other day on which banks in New York, New York, United States or Berlin, Germany are permitted or required to be closed.

      1.10 “ Commercialization ” means the marketing, promotion, advertising, selling and distribution of a Licensed Product after Marketing Approval has been obtained in such country. The term “ Commercialize ” has a correlative meaning.

      1.11 “ Commercially Reasonable Efforts ” means those diligent efforts consistent with the exercise of prudent scientific and business judgment that a company within the pharmaceutical industry would reasonably devote to a product of similar market potential or profit potential resulting from its own research efforts, based on conditions then prevailing,

which in any event will include (if applicable in the context of the provision of this Agreement where this term is used): (a) promptly assigning responsibility for development and commercialization activities to specific employees who are held accountable for progress and monitoring such progress on an on-going basis, (b) setting and consistently seeking to achieve specific and meaningful objectives and timelines for carrying out such development and commercialization activities, (c) consistently making and implementing decisions and allocating resources designed to advance progress with respect to such objectives and timelines, and (d) employing compensation systems for its employees that are no less favorable than the compensation systems the applicable Party applies with respect to its other programs with products of similar market potential, in order to reasonably incentivize such employees to achieve such objectives.

      1.12 “ Committee ” means the joint steering committee (or JSC, as defined in Section 2.2), the joint development committee (or JDC, as defined in Section 2.3), the joint commercialization committee (or JCC, as defined in Section 2.4), or any other committee authorized by the JSC pursuant to Section 2.2 of this Agreement, as the case may be.

      1.13 “ Confidential Information ” has the meaning set forth in Section 12.1.

      1.14 “ Controlled ” means, with respect to any Know-How, Patent, other intellectual property right, data, or regulatory filing, the possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to assign, or grant a license, sublicense or other right to or under, such Know-How, Patent, other intellectual property right, data, or regulatory filing as provided for herein without violating the terms of any agreement or other arrangements with any Third Party. The term “Control” has a correlative meaning.

      1.15 “ Development Plan ” has the meaning set forth in Section 3.1.1.

      1.16 “ Development Program ” means the program of development described in the Development Plan, as amended from time to time.

      1.17 “ Effective Date ” has the meaning set forth in Section 13.1.

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

      1.19 “ First Commercial Sale ” means, with respect to a Licensed Product and a country, the first commercial sale after receipt of Marketing Approval of such Licensed 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 Licensed Product is supplied with or without charge will not constitute a First Commercial Sale.

      1.20 “ FTE ” means a full-time person, or in the case of less than a full- time dedicated person, a full-time, equivalent person year.

      1.21 “ GAAP ” means generally accepted accounting principles, consistently applied, in the United States.

      1.22 “ GCP ” means the FDA regulations and applicable ICH guidelines for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of

clinical trials, as applicable to the development of Licensed Product from time to time during the Term, including 21 C.F.R. Part 11, 50, 54, 56, 312, and 314 as amended from time to time.

      1.23 “ GLP ” means the FDA regulations and applicable ICH guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA, as applicable to the development of Licensed Product from time to time during the Term, including 21 C.F.R. Part 58 as amended from time to time.

      1.24 “ Growth Rate Goal ” means, with respect to the launch in the Territory of a particular Additional Formulation Product that has received Marketing Approval or a Licensed Product for an indication other than hereditary angioedema or drug-induced angioedema, an increase of at least * * * in the annualized growth rate of aggregate sales of Licensed Products in the Territory at the end of the 12-month period following such launch. By way of example, if the annualized growth rate for sales of Licensed Products in the Territory is * * * prior to the launch of an Additional Formulation Product, then the annualized growth rate for aggregate sales of Licensed Products in the Territory will need to reach * * * upon the * * * anniversary of such launch in order for the Growth Rate Goal to be met.

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

      1.26 “ Icatibant ” means the pharmaceutical substance identified as D-Arginyl-L-arginyl-L-prolyl-L-[(4R)-4-hydroxyprolyl]-glycyl-L-[3-(2-thienyl)alanyl]-L-seryl-D-(1,2, 3,4-tetrahydro-isoquinolin-3-yl-carbonyl)-L-(3aS,7aS)-octahydroindol-2-yl-carbonyl]-L-arginine acetate.

      1.27 “ Jerini House Marks ” means any trademarks or trade names used or registered by Jerini or its Affiliates at any time during the Term to identify itself.

      1.28 “ Jerini Invention ” means any invention, discovery or Know-How that relates to Icatibant or any Licensed Product and that is conceived, made or generated, solely or jointly by Jerini, its Affiliates, agents, or independent contractors during the Term, but excluding any Assigned Invention.

      1.29 “ Jerini R/A Product ” means any Licensed Product that: (i) has been developed by Jerini for approval outside the Territory in an indication within the R/A Field and (ii) is the subject of an MAA filed by Jerini outside the Territory, which MAA contains any data of Phase III Clinical Trials conducted by or on behalf of Kos in connection with the development of such Licensed Product in the R/A Field in the Territory.

      1.30 “ Know-How ” means any non-public knowledge, experience, know-how, technology, information, and data, including formulas and formulations, processes, techniques, unpatented inventions, discoveries, ideas, developments, test procedures, and results, together with all documents and files embodying the foregoing.

      1.31 “ Kos House Marks ” means any trademarks or trade names used or registered by Kos or its Affiliates at any time during the Term to identify itself.

      1.32 “ Kos Invention ” means any invention, discovery or Know-How that relates to Icatibant or any Licensed Product and that is conceived, made or generated, solely

or jointly by Kos, or its Affiliates, agents, Sublicensees, or independent contractors during the Term, but excluding any Assigned Invention.

      1.33 “ Licensed Field ” means the Angioedema Field and the R/A Field.

      1.34 “ Licensed Know-How ” means any Know-How that is necessary or useful for the development, manufacture or commercialization of Licensed Products in the Licensed Field and that is Controlled by or on behalf of Jerini or its Affiliates during the Term, including any Jerini Invention or any Assigned Invention owned by or assigned to Jerini pursuant to Section 10.2, but excluding any Know-How not Controlled by or on behalf of Jerini or Its Affiliates on the Effective Date with respect to which Jerini owes royalty or other payment obligations to a Third Party and that has not been expressly included in the Licensed Know-How pursuant to Section 3.4.1.

      1.35 “ Licensed Patents ” means the following Patents, each to the extent that such Patent would be infringed by the manufacture, use or sale of a Licensed Product in the Licensed Field: (i) the Patents Controlled by Jerini or its Affiliates as of the Effective Date pursuant to a license under the Aventis Agreement, as listed in Exhibit A (such Patents, the “ Aventis Patents ”), (ii) any Patents Controlled by Jerini or its Affiliates during the Term that claim Jerini Inventions, (iii) any Patents Controlled by Jerini or its Affiliates during the Term that claim Assigned Inventions, (iv) any Patents within Third Party Technology that have been expressly included in the Licensed Patents pursuant to Section 3.4.1, and (v) any Blocking Patents Controlled by Jerini or its Affiliates during the Term.

      1.36 “ Licensed Product ” means any product that consists of, comprises or includes Icatibant or any of its salts, esters, hydrates, isomers, prodrugs and metabolites in any formulation.

      1.37 “ Licensed Technology ” means the Licensed Patents and the Licensed Know-How.

      1.38 “ MAA ” means the marketing authorization application filed with the European Medicines Agency for the applicable Licensed Product under the centralized procedure, or if the centralized procedure is not used, the equivalent application filed for the applicable Licensed Product in three of the following countries: France, Germany, Italy, Spain and the United Kingdom.

      1.39 “ Marketing Approval ” means the approvals of any federal, state or local regulatory agency, department, bureau or other government entity in a country,

     that are necessary to be obtained prior to the commercial sale of a Licensed Product in that country.

      1.40 “ Marketing Plan ” has the meaning set forth in Section 5.1.

      1.41 “ NDA ” means a New Drug Application filed with the FDA in the United States, and the corresponding application filed with the corresponding regulatory agency in any other country in the Territory.

      1.42 “ Net Sales ” means the recorded gross sales of Licensed Products by a Party, its Affiliates, licensees or Sublicensees to Third Parties (that are not licensees or Sublicensees) in accordance with GAAP, less the total of: (i) allowances for trade, quantity, and cash discounts; (ii) excise, sales and other consumption taxes and customs duties to the extent

included in the invoice price; (iii) freight, insurance and other transportation charges to the extent included in the invoice price; (iv) provisions for actual or expected allowances or credits to Third Parties by reason of rejections and defects; (v) provisions for returns or retroactive price reductions; and (vi) compulsory payments, chargebacks and rebates accrued, paid or deducted pursuant to agreements (including, but not limited to managed care agreements) or governmental regulations. Any such recordations, provisions or deductions will be made in accordance with reasonable and customary industry practices and in accordance with consistently applied GAAP.

      1.43 “ Patents ” means (a) all patents and patent applications in any country or supranational jurisdiction, and (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like, and any provisional applications, of any such patents or patent applications.

      1.44 “ Phase I Clinical Trial ” means a clinical study in humans to determine the pharmacokinetics and safety of a pharmaceutical product.

      1.45 “ Phase II Clinical Trial ” means a clinical study in humans suffering from a disease or condition to obtain data on the safety, dose ranging and efficacy of a pharmaceutical product.

      1.46 “ Phase III Clinical Trial ” means a confirmatory clinical study in humans of the efficacy and safety of a pharmaceutical product that is prospectively designed to demonstrate that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product.

      1.47 “ Phase IV Clinical Trial ” means a clinical study in humans of a pharmaceutical product performed following Marketing Approval of such product to compare the product to a competitor, to explore additional patient populations, or to further study any adverse events.

      1.48 “ Product Trademarks ” means any trademarks, trade dress (including packaging design), logos, slogans, and designs, whether or not registered in the Territory, used to identify or promote a Licensed Product in the Territory, but excluding any Kos House Marks and Jerini House Marks.

      1.49 “ Promotional Materials ” means all written, printed, video or graphic advertising, promotional, educational and communication materials (other than product labels and package inserts) for marketing, advertising and promotion of the Licensed Products, including, without limitation, copyrights in any such materials and all designs, industrial designs, design patents, design registrations, design patent applications and URLs developed or used in connection with such materials, for use by (a) a sales representative or (b) in or on advertisements, web sites or direct mail pieces.

      1.50 “ RAIL Field ” means the treatment of any form of resistant ascites in liver cirrhosis.

      1.51 “ R/A Field ” means the RAIL Field and the Asthma Field.

      1.52 “ Sanofi-Aventis ” means Aventis Pharma Deutschland GmbH or any

successor-in-interest thereof with respect to the Aventis Agreement.

      1.53 “ Sublicense Agreement ” means any agreement under which Kos grants an Affiliate or a Third Party a sublicense, option to sublicense, or grant of any other right relating to any Licensed Technology in accordance with Section 8.2 allowing an Affiliate or Third Party to Commercialize one or more Licensed Product.

      1.54 “ Sublicensee ” means any Third Party that has entered into a Sublicense Agreement.

      1.55 “" Term ” has the meaning assigned to it in Section 13.1.

      1.56 “" Territory ” means the United States and Canada.

      1.57 “ Third Party ” means any party other than Jerini, Kos, or their respective Affiliates.

      1.58 “ Third Party Technology ” means any Patents, Know-How, inventions, or other intellectual property owned or controlled by a Third Party but not Controlled by a Party or its Affiliates.

      1.59 “ United States ” means the United States of America, and any of its territories and possessions, including Puerto Rico.

      1.60 “ Valid Claim ” means any pending claim in any pending patent application within the Licensed Patents or any claim of any issued and unexpired patent within the Licensed Patents that has not been disclaimed or held invalid or unenforceable by judgment or decree entered in any judicial proceeding that is not further reviewable through the exhaustion of all permissible applications for rehearing or review by a superior tribunal, or through the expiration of the time permitted for such applications.

      1.61 “ Wülfing Manufacturing Agreement ” means that certain Contract Manufacturing Agreement dated February 26, 2004 by and between Wülfing Pharma GmbH and Jerini AG.

      2.1 General . The Parties desire to establish three (3) committees to oversee the Parties’ collaboration under this Agreement and to facilitate communications between the Parties with respect to the development and commercialization of each Licensed Product. Each of such Committees will have the responsibilities and authority allocated to it in this Section 2.

      2.2 Joint Steering Committee . Promptly following the Effective Date, the Parties will create a joint steering committee (“ JSC ”). The tasks of the JSC will be (a) to oversee the development and commercialization of Licensed Product in the Territory, (b) to coordinate and delegate the activities of the other Committees, (c) to authorize the formation of additional committees, including, but not limited to, a technical operations committee if necessary, (d) to monitor the

progress of and coordinate the activities undertaken pursuant to the Development Plan, (e) to review and approve the Marketing Plans and any updates or amendments thereto proposed by the JCC (as defined in Section 2.4), (f) to monitor the progress of, and coordinate the activities undertaken pursuant to, the Marketing Plans, (g) to review the product lifecycle plans for Licensed Products for the Territory, including indication and label expansions, new dosage forms, and new formulations or delivery systems, (h) to resolve disagreements arising in the other Committees, and (i) to take such other actions as are expressly delegated to the JSC in this Agreement. The JSC will have the membership and will operate by the procedures set forth in Section 2.5.

      2.3 Joint Development Committee . Promptly following the Effective Date, the Parties will create a joint development committee (“ JDC ”). The tasks of the JDC will be (a) to oversee the development of Licensed Products in the Territory, (b) to determine the development strategy for Licensed Products in the Territory, (c) to facilitate the management and implementation of the Parties’ development activities hereunder, (d) to review and approve updates and amendments to the Development Plan proposed by Jerini (with respect to development in the Angioedema Field) or by Kos (with respect to development in the R/A Field), and (e) to take such other actions as are expressly delegated to the JDC in this Agreement or by the JSC. The JDC will have the membership and will operate by the procedures set forth in Section 2.5.

      2.4 Joint Commercialization Committee . Promptly following the Effective Date, the Parties will create a joint commercialization committee (“ JCC ”). The tasks of the JCC will be (a) to oversee the Commercialization of Licensed Product in the Angioedema Field in the Territory, (b) to prepare and update the Marketing Plans by adapting, wherever applicable, Jerini’s global marketing and branding strategy for Licensed Product in the Angioedema Field to the market in the Territory (the full documentation of which strategy Jerini shall provide to Kos on or before December 1, 2005), (c) to prepare the pricing and reimbursement strategy, (d) to facilitate the management and implementation of the Parties’ Commercialization activities hereunder, and (e) to take such other actions as are expressly delegated to the JCC in this Agreement or by the JSC. The JCC will have the membership and will operate by the procedures set forth in Section 2.5.

      2.5 Membership and Procedures .

           2.5.1 Membership. Each Committee will be comprised of no more than six (6) members and each Party will designate an equal number of representatives with appropriate expertise to serve as members of each Committee. Each Party may replace its representatives on a Committee at any time upon written notice to the other Party.

           2.5.2 Chairpersons. Each Committee will be led by a chairperson selected in accordance with this Section 2.5.2. The chairperson will be responsible for calling meetings and preparing and circulating an agenda in advance of each meeting of the applicable Committee. For each Committee, the Parties will alternate selecting the chairperson on a calendar year basis, at the end of each calendar year during the Term (other than calendar year 2005). The initial chairpersons will be selected as follows: (a) Kos will appoint the initial chairpersons for the JSC and the JCC, each of whose term will continue from the Effective Date until December 31, 2006; (b) Jerini will appoint the initial chairperson for the JDC, whose term will continue from the Effective Date until December 31, 2006.

           2.5.3 Meetings.

                (a)  Each Committee will hold meetings at such times as it elects to do so, but in no event will meetings be held less frequently than quarterly (based upon the calendar

year) through the first anniversary of the Effective Date and twice per year thereafter. Committee meetings may be held in person alternating between the US offices of Kos and the German offices of Jerini (or at other mutually agreeable locations) or by means of telecommunication (telephone, video, or web conferences); provided , that at least two meetings per year will be held in person, unless the Parties agree otherwise.

                (b)  Other employees of each Party involved in the development, manufacture or Commercialization of Licensed Product but who are not members of a Committee may attend meetings of any Committee as nonvoting participants, and, with the consent of each Party (not to be unreasonably withheld or delayed), consultants, representatives, or advisors involved in the development, manufacture or commercialization of Licensed Product may attend meetings as nonvoting observers; provided , that such Third Party representatives are under obligations of confidentiality and non-use applicable to the Confidential Information of each Party and that are at least as stringent as those set forth in Section 12.

                (c)  Each Party will be responsible for all of its own expenses of participating in each Committee. Following any Committee meeting, the applicable chairperson will be responsible for preparing and issuing minutes of such meeting within thirty (30) days thereafter. Such minutes will not be finalized until the chairperson and a representative of the other Party have reviewed and confirmed the accuracy of such minutes in writing; provided , that if the Parties cannot agree as to the content of the minutes, such minutes will be finalized to reflect such disagreement.

           2.5.4 Limitations of Powers . Each Committee will have only such powers as are specifically delegated to it hereunder or by the JSC. Without limiting the generality of the foregoing, no Committee will have any power to amend this Agreement, except for changes to the Development Plan and the Marketing Plan made in accordance with the decision making provisions of Section 2.6.

      2.6 Decision-Making .

           2.6.1 Subject to the terms of this Section 2.6, each Committee will take action by unanimous vote with each Party having a single vote, irrespective of the number of representatives actually in attendance at a meeting, or by a written resolution signed by the designated representatives of each of the Parties. If a Committee fails to reach unanimous consent on a particular matter within thirty (30) days of a Party having requested a formal vote on such matter (such unresolved matter a “ Disagreement ”), then: (a) any Disagreement arising in the JDC or JCC will be referred to the JSC for resolution, and (b) any Disagreement arising in the JSC will be subject to the resolution procedures described in Section 2.6.2 below.

           2.6.2 In the event of a Disagreement arising in the JSC, either Party may provide written notice of such Disagreement (a “ Notice of Disagreement ”) to the Chief Executive Officer of the other Party. The Chief Executive Officers of each of the Parties will meet at least once in person or by means of telecommunication (telephone, video, or web conferences) to discuss the matter on which the JSC failed to reach unanimous consent and use their good faith efforts to resolve the Disagreement within thirty (30) days after receipt of the Notice of Disagreement by the applicable Chief Executive Officer of a Party.

           2.6.3 If any such Disagreement is not resolved by the Chief Executive Officers within such thirty (30) day period, then the Disagreement will be resolved as follows:

                (a)  the Chief Executive Officer of * * * will have the authority, subject to Section 2.6.3(b) below, to finally resolve any Disagreement relating to (i) * * *, and (ii) * * *;

                (b)  the Chief Executive Officer of * * * will have the authority to finally resolve any Disagreement relating to (i) * * *, and (ii) * * *;

           2.6.4 Neither Party will exercise its right to finally resolve a dispute at a committee in accordance with this Section 2.6 in a manner that excuses such Party from any of its obligations specifically enumerated under this Agreement.

           2.6.5 Notwithstanding this Section 2.6, any dispute regarding the interpretation of this Agreement or any alleged breach of this Agreement will be resolved in accordance with the terms of Section 16.4.

3. Development of Licensed Product

      3.1 Development Program .

           3.1.1 Development Plan .

                (a)  The development of Licensed Product under this Agreement in each indication in the Licensed Field will be governed by a written plan agreed upon by the JDC (such plan, the “ Development Plan ”). The Development Plan will set forth the budgets, objectives, planned tasks, resource allocations and timelines for the conduct of the development activities with respect to Licensed Product in the Licensed Field in the Territory. The initial Development Plan is attached to this Agreement as Exhibit B . Subject to Section 12.9, Jerini will have the right to provide reports, summaries, and other information contained therein to Sanofi-Aventis to the extent required pursuant to Section 3.2 of the Aventis Agreement.

                (b)  Within * * * following the Effective Date, and thereafter from time to time during the Term, the JDC will amend the Development Plan as may be necessary or appropriate to reflect the results of the development activities under this Agreement and the plans of the Parties for the development of Licensed Product in the Licensed Field in the Territory. Further, either Party may propose amendments to the Development Plan for consideration by the JDC. Any such proposal will include an updated budget for development expenses set forth in the Development Plan in order to reflect the proposed changes to the Development Plan. Upon receipt of a proposed change or amendment to the Development Plan, the JDC will promptly review such proposal and will update the Development Plan as it deems necessary and appropriate.

           3.1.2 Performance . Each Party will be responsible for the performance of the activities assigned to such Party in the Development Plan; provided , that unless otherwise agreed by the Parties, Jerini will perform the activities relating to the development of Licensed Product in the Angioedema Field, and Kos will perform the activities relating to the development of Licensed Product in the R/A Field. Each Party will use Commercially Reasonable Efforts to conduct such activities in a good scientific manner and in compliance in all material respects with all applicable laws. All efforts of a Party’s Affiliates, Third Party contractors and Sublicensees relating to a Party’s responsibilities hereunder will be considered efforts of such Party for the purpose of determining such Party’s compliance with its obligations under this Section 3.1.2.

           3.1.3 Records. All activities conducted by or on behalf of a Party in the Development Program will be completely and accurately recorded, in sufficient detail and in good scientific manner and according to the governing regulatory requirements such as GLP and GCP and archived as requested by regulatory regulations and separated from other parties work and distinct from other work being conducted by such Party. Each Party will also retain all records required by applicable law to be maintained in connection with the Development Program.

           3.1.4 Expenses.

                (a)  Jerini will perform * * * the Development Program in connection with the development of each Licensed Product in the Angioedema Field in each country in the Territory until receipt of Marketing Approval for such Licensed Product in such country having the applicable indication in the Angioedema Field and any other conditions for approval stipulated in the approval letter. * * * (i) * * * Jerini to perform Phase IV Clinical Trials other than those required by the FDA as a condition of granting Marketing Approval for a Licensed Product in the Angioedema Field, or (ii) * * * Jerini to establish early access or compassionate use programs with a Licensed Product in the Angioedema Field that are not included in the Development Plan as of the Effective Date.

                (b)  Kos will perform * * * the Development Program in connection with the development of each Licensed Product in the R/A Field for each country in the Territory.

      3.2 Progress Reports. Each Party will inform the JDC of the performance of the Development Plan through quarterly progress reports submitted in writing to the JDC. In addition, at any time upon either Party’s request, the Parties will exchange copies of any final reports of any clinical studies performed by the Parties, and any other information or data reasonably requested by a Party relating to the Development Plan.

     3.3 Diligence.

           3.3.1 Angioedema Field . Jerini will use its Commercially Reasonable Efforts to develop and obtain Marketing Approval of one or more Licensed Products in the Angioedema Field in the Territory.

           3.3.2 R/A Field .

                (a)  Kos will use its Commercially Reasonable Efforts to develop and obtain Marketing Approval of (ii) one or more Licensed Products in the RAIL Field in both countries of the Territory, and (ii) one or more Licensed Products in the Asthma Field in both countries of the Territory.

                (b)  The portion of the license contained in Section 8.1 of this Agreement relating to the RAIL Field may be terminated by Jerini * * * to Kos: (i) after * * * if Kos has not initiated the first Phase II Clinical Trial of the Licensed Product in the RAIL Field by such date, (ii) following final study results of the first Phase II Clinical Trial of the Licensed Product in the RAIL Field, at the end of any * * * period during which Kos is not performing clinical trials with respect to Licensed Products in the RAIL Field, or (iii) at any time after completion of the clinical trials

referenced in clause (ii) of this subsection, if Kos fails to use its Commercially Reasonable Efforts to obtain Marketing Approval of one or more Licensed Products in the RAIL Field as provided in Section 3.3.2(a) above; provided , that, in the case of either (i), (ii) or (iii), Kos has not commenced such activities or efforts * * * * * * from Jerini to Kos under this subsection; and further provided , that the time periods for Kos’s obligations hereunder shall be extended if (and to the extent that) Jerini does not deliver in a timely manner Licensed Product in accordance with the terms of the Supply Agreement.

                (c)  The portion of the license contained in Section 8.1 of this Agreement relating to the Asthma Field may be terminated by Jerini * * * to Kos: (i) after * * * if Kos has not initiated the first clinical trial of the Licensed Product in the Asthma Field by such date, (ii) following commencement of the first clinical trial of the Licensed Product in the Asthma Field, at the end of * * * during which Kos is not performing clinical trials with respect to Licensed Products in the Asthma Field, or (iii) at any time after completion of the clinical trials referenced in clause (ii) of this subsection, if Kos fails to use its Commercially Reasonable Efforts to obtain Marketing Approval of one or more Licensed Products in the Asthma Field as provided in Section 3.3.2(a) above; provided , that, in the case of either (i), (ii) or (iii), Kos has not commenced such activities or efforts * * * from Jerini to Kos under this subsection; and further provided , that the time periods for Kos’s obligations hereunder shall be extended if (and to the extent that) Jerini does not deliver in a timely manner Licensed Product in accordance with the terms of the Supply Agreement.

                (d)  A partial termination of the license pursuant to the respective subsections of this Section will be, notwithstanding any other provision of this Agreement to the contrary, * * *.

      3.4 Third Party Technology .

           3.4.1 Obtained by Jerini . If after the Effective Date Jerini or any of its Affiliates (i) acquires an assignment of, or license under, Third Party Technology (other than Blocking Patents) for use in connection with the research, development, Commercialization or manufacture of Licensed Products in or for the Territory, and (ii) would be subject to payment obligations to such Third Party on account of Kos’s exploitation of such Third Party Technology in connection with the research, development, Commercialization or manufacture of Licensed Products in or for the Territory, then Jerini will promptly provide Kos with written notice of such acquisition and the additional financial terms to which Jerini would be subject if Kos were to exploit a license under such Third Party Technology; provided , that in the case of a worldwide assignment or license of such Third Party Technology, in no event will such terms provide for an * * * with respect to the development and Commercialization of the Licensed Product in the Territory except with the prior agreement of Kos. If Kos desires to obtain such license, this Agreement will be deemed amended to reflect such additional financial terms and to provide that the applicable Know-How, data, or filings will be included in “Licensed Know-How” under this Agreement and any applicable Patents will be included in “Licensed Patents” under this Agreement.

           3.4.2 Obtained by Kos . If after the Effective Date Kos or any of its Affiliates (i) acquires an assignment of, or license under, Third Party Technology (other than Blocking Patents) for use in connection with the research, development, Commercialization or manufacture of Licensed Products in the R/A Field outside the Territory, and (ii) would be subject to payment obligations to such Third Party on account of Jerini’s exploitation of such Third Party Technology in connection with the research, development, Commercialization or manufacture of Licensed Products outside the Territory,

then Kos will `vide Jerini with written notice of such acquisition and the additional financial terms to which Kos would be subject if Jerini were to exploit such license; provided , that in the case of a worldwide assignment or license of such Third Party Technology, in no event will such terms provide for an * * * with respect to the development and Commercialization of the Licensed Product outside the Territory except with the prior agreement of Jerini. If Jerini desires to obtain such license, this Agreement will be deemed amended to reflect such additional financial terms and to provide that the applicable Know-How, data, or filings will be deemed “Kos Inventions” under this Agreement.

           3.4.3 Blocking Patents . If Kos determines that it is necessary to obtain a license or other rights to one or more Blocking Patents for the research, development, manufacture or Commercialization of any Licensed Product in or for the Territory, then Kos will be solely responsible for obtaining such license. * * * under this Agreement, as described in further detail in Section 7.5.3 of this Agreement.

4. Regulatory Matters

      4.1 Responsibility for Regulatory Affairs .

           4.1.1 Angioedema Field .

                (a)  Unless otherwise agreed in writing by the Parties, Jerini will be responsible for all regulatory affairs relating to Licensed Product in the Angioedema Field in both countries of the Territory, including preparing and submitting NDAs and seeking Marketing Approvals in accordance with the applicable Development Plan and preparing all reports necessary as part of any NDA. All such NDAs and Marketing Approvals will be filed and held in the name of Jerini.

                (b)  Subject to the provisions governing pharmacovigilance in Section 4.5 of this Agreement and the agreements contemplated in Section 4.5 of this Agreement, Jerini will consult in advance with Kos with respect to any filings to be made by Jerini in accordance with the terms of this Section 4.1.1 (including INDs and NDAs) and with respect to material and substantive correspondence with regulatory authorities (including proposed responses to inquiries received from regulatory authorities), and will consider in good faith any comments Kos may have with respect to any such filings and responses; provided , that Kos will provide such comments (if any) within 5 Business Days following receipt of the proposed correspondence from Jerini.

           4.1.2 R/A Field .

                (a)  Unless otherwise agreed in writing by the Parties, Kos will be responsible for all regulatory affairs relating to Licensed Products in the R/A Field in both countries of the Territory in accordance with the applicable Development Plan, including preparing and submitting NDAs and seeking Marketing Approvals in accordance with the applicable Development Plan and preparing all reports necessary as part of any NDA. All such NDAs and Marketing Approvals will be filed and held in the name of Kos.

                (b)  Subject to the provisions governing pharmacovigilance in Section 4.5 of this Agreement and the agreements contemplated in Section 4.5 of this Agreement, Kos will consult in advance with Jerini with respect to any filings to be made by Kos in accordance with the terms of this Section

4.1.2 (including INDs and NDAs) and with respect to material and substantive correspondence with regulatory authorities (including proposed responses to inquiries received from regulatory authorities), and will consider in good faith any comments Jerini may have with respect to any such filings and responses; provided , that Jerini will provide such comments (if any) within 5 Business Days following receipt of the proposed correspondence from Kos.

      4.2 Access, Use and Reference Rights to Data and Filings .

           4.2.1 Access to Data. Upon the filing of any NDA by a Party for Licensed Product in the Territory, such Party will provide the other Party with unlimited access to an electronic version of (i) any clinical safety data maintained or otherwise Controlled by such Party, and (ii) any clinical efficacy data relating to the Licensed Field and maintained or otherwise Controlled by such Party (to the extent it is technically feasible for such Party to segregate such data by indication and protect the confidentiality of information related to indications outside the Licensed Field), in each case for the purpose of promoting and commercializing Licensed Products in accordance with the terms and conditions of this Agreement. Jerini agrees to use its Commercially Reasonable Efforts to have such data segregated by indication from the outset or to segregate such data subsequently and to protect the confidentiality of information related to indications outside the Licensed Field.

           4.2.2 Grant by Jerini . During the Term, Jerini will provide to Kos access during regular business hours and at mutually agreeable times to all other data (including pre-clinical and clinical data and data) and all filings (including IND and NDA dossiers) with respect to Icatibant and Licensed Product applicable to the Licensed Field and that are Controlled by Jerini. Further, Jerini hereby grants Kos the right to use and reference all data (including pre-clinical and clinical data) and regulatory filings and approvals Controlled by Jerini relating to Licensed Product in the Licensed Field (including any NDAs or MAAs) for the purpose of developing and commercializing Licensed Product in the Licensed Field and in the Territory in accordance with the terms of this Agreement (including in Kos’s regulatory filings for the Licensed Product in the Territory). Such right of reference will be transferable to Kos’s Affiliates and Sublicensees. To the extent that any such data or regulatory filings are held by a Third Party, Jerini will arrange direct access to the portions of such data and regulatory filings that are relevant to the activities of Kos contemplated by this Agreement. Further, upon request of Kos, Jerini will make available necessary personnel to participate in meetings with regulatory authorities within the Territory as may be required by Kos in connection with the development and obtaining Marketing Approval of Licensed Products in the Territory in the R/A Field;* * *. Any information obtained by Kos pursuant to this Section 4.2.2 will be deemed Confidential Information of Jerini.

           4.2.3 Grant by Kos . During the Term, Kos will provide to Jerini access during regular business hours and at mutually agreeable times to all data (including pre-clinical and clinical data) and all filings (including IND and NDA dossiers) with respect to Icatibant and Licensed Product applicable to the Licensed Field and that are Controlled by Kos. Further, Kos hereby grants Jerini the right to use and reference all data (including pre-clinical and clinical data) and regulatory filings Controlled by Kos relating to Licensed Product for the purpose of developing and commercializing Licensed Products in the Angioedema Field in the Territory and developing and commercializing Licensed Products outside the Territory. * * *. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then Kos will arrange direct access to the portions of such data and regulatory filings that are relevant to such activities. Further, upon request of Jerini, Kos will make available its personnel to participate in meetings with regulatory authorities in countries outside the Territory as may be

required by Jerini in connection with the development and obtaining Marketing Approval of Licensed Products in such countries;* * * . Any information obtained by Jerini pursuant to this Section 4.2.3 will be deemed Confidential Information of Kos.

      4.3 Correspondence and Meetings with Regulatory Authorities.

           4.3.1 Each Party will promptly provide the other Party with copies of any correspondence received from or sent to any governmental authority that is: (i) required to be provided to such other Party under applicable laws, regulations, or guidelines, or (ii) material to Icatibant or the development or Commercialization of any Licensed Product in the Licensed Field in the Territory (with respect to correspondence to be provided to Kos) or outside the Territory (with respect to correspondence to be provided to Jerini).

           4.3.2 The Party responsible for preparing and filing the NDA for Licensed Product developed in the Licensed Field as provided in Section 4.1 (the “ Responsible Party ”) will provide the other Party with reasonable notice of any meeting or substantive or material conference call with any governmental authority relating to any NDA or Marketing Approval for Licensed Product in the Territory, and such other Party will have the right to have one representative participate in any such meeting or material conference call as a silent observer as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide such other Party notice of any such meeting or conference call, the Responsible Party will immediately thereafter provide such other Party with a reasonably detailed summary of any such meeting or conference call. The Responsible Party will promptly, but in no event more than two (2) Business Days after receipt, furnish the other Party with copies of all substantive or material documents or correspondence that the Responsible Party has had with or receives from any governmental authority, and contact reports concerning substantive or material conversations or substantive meetings with any governmental authority, in each case relating to any NDA or Marketing Approval (including without limitation any minutes from a meeting with respect thereto).

      4.4 Recalls and Withdrawals .

           4.4.1 As used in this Section 4.4, “recall” means a safety recall of one or more lots of Licensed Product due to concerns specific to such lots, and “withdrawal” means the removal of a Licensed Product from the market entirely. +!

           4.4.2 If any governmental authority informs a Party that it proposes or plans to initiate any action to require a recall or withdrawal of a Licensed Product from the market, the Party receiving such information will notify the other Party no later than one (1) Business Day after receipt of such information.

           4.4.3 * * * , in good faith and in consultation with the JSC, to initiate a recall or withdrawal of Licensed Product in * * * in the Territory. * * * may decide, in good faith and in consultation with the JSC, to initiate a recall or withdrawal of Licensed Product * * * in the Territory.

           4.4.4 Before * * * a recall or withdrawal pursuant to Section 4.4.3, or upon the request for a recall or withdrawal by the other Party, the Parties will promptly and in good faith discuss the reasons therefor. Each Party will provide to the other Party without delay any information or documentation based on which it determines that a Licensed Product should be

recalled or withdrawn. Under no circumstances will either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party will have any right to object to a recall or withdrawal requested by the other Party for failure of a Licensed Product to meet the applicable specifications, for material safety concerns, or for the manufacture of such Licensed Product in a manner that does not comply with applicable laws. In the event of any recall or withdrawal for Licensed Product in the Territory, Kos will implement any necessary action, with assistance from Jerini as reasonably requested by Kos

           4.4.5 Where and to the extent that the need for a recall is necessitated by negligence or a failure on the part of either Party to comply with any of its obligations under this Agreement or applicable law, or is otherwise due to any defect or condition of the Licensed Products that is the responsibility of such Party hereunder,* * * . Where and to the extent that the need for a withdrawal is necessitated of the Licensed Products,* * *.

      4.5 Pharmacovigilance . The Parties will exchange all pharmacovigilance relevant information while any Licensed Product is under development pursuant to a separate pharmacovigilance agreement to be executed within * * * after the Effective Date. * * * will have responsibility for tracking and filings and, * * * prior to the anticipated First Commercial Sale of any Licensed Product hereunder, the Parties’ respective pharmacovigilance departments will meet and determine the approach otherwise to be taken for the collection, review and assessment of information related to adverse events associated with Licensed Product. Such approach will be documented in a separate and appropriate written pharmacovigilance agreement between the Parties which will be negotiated by the Parties in good faith. Any such pharmacovigilance agreements will be harmonized with the terms of the pharmacovigilance agreement between Jerini and Sanofi-Aventis such that Jerini can comply with its reporting obligations under such agreement with Sanofi-Aventis.

      4.6 Regulatory Obligations during Commercialization .

           4.6.1 Angioedema Field . As between the Parties, Jerini will * * * all regulatory filings and Marketing Approvals for Licensed Product developed pursuant to this Agreement for the Angioedema Field in both countries of the Territory, including all INDs and NDAs. As between the Parties, Jerini will be solely responsible for all activities in connection with maintaining such Marketing Approvals and other regulatory approvals required for the Commercialization and manufacture of Licensed Product in the Angioedema Field, including communicating and preparing and filing all reports (including adverse drug experience reports) with the applicable regulatory authorities, as described in further detail in this Section 4.

           4.6.2 R/A Field . As between the Parties, Kos will * * * all regulatory filings and Marketing Approvals for Licensed Product developed pursuant to this Agreement for the R/A Field in both countries of the Territory, including all INDs and NDAs. As between the Parties, Kos will be solely responsible for all activities in connection with maintaining such Marketing Approvals and other regulatory approvals required for the Commercialization and manufacture of Licensed Product in the R/A Field in the Territory, including communicating and preparing and filing all reports (including adverse drug experience reports) with the applicable regulatory authorities, as described in further detail in this Section 4.

      4.7 HSR Act .

           4.7.1 To the extent required by the HSR Act, each Party will (i) file or cause to be filed, as promptly as practicable after the date hereof, but in no event later than the

tenth Business Day thereafter, with the United States Federal Trade Commission (“ FTC ”) and the United States Department of Justice (“ DOJ ”), all reports and other documents required to be filed by such Party under the HSR Act concerning the transactions contemplated hereby and (ii) promptly comply with or cause to be complied with any requests by the FTC or DOJ for additional information concerning such transactions, in each case so that the waiting period applicable to this Agreement and the transactions contemplated hereby under the HSR Act will expire as soon as practicable after the date hereof. Each Party agrees to request, and to cooperate with the other Party in requesting, early termination of any applicable waiting period under the HSR Act. * * *.

           4.7.2 * * *, to the extent then required the HSR Act, each Party will (i) file or cause to be filed, as promptly as practicable, with the FTC and the DOJ, all reports and other documents required to be filed by such Party under the HSR Act concerning the transactions contemplated hereby and (ii) promptly comply with or cause to be complied with any requests by the FTC or DOJ for additional information concerning such transactions, in each case so that the waiting period applicable to the effectiveness of the transfer of manufacturing rights contemplated hereby under the HSR Act will expire as soon as practicable. Each Party agrees to request, and to cooperate with the other Party in requesting, early termination of any applicable waiting period under the HSR Act. * * *.

5. Commercialization of Licensed Product

      5.1 Marketing Plans.

           5.1.1 * * * will prepare, and the JCC will review and approve, written launch and annual marketing plans, including sales forecasts and product orders, with respect to the Commercialization of each Licensed Product in the Licensed Field in the Territory (each a “ Marketing Plan ”), and any amendments or updates thereto. The initial Marketing Plan for Commercialization of Licensed Product in the Angioedema Field is attached to this Agreement as Exhibit C , and will be updated by * * * and submitted to the JCC for review and approval within * * * under Section 2.4. Promptly after the initiation of the first Phase III Clinical Trial in a particular country in the Territory, * * * will prepare, and the JCC will review and approve, the Marketing Plan for Commercialization of Licensed Product in the R/A Field in such country; provided , that each such Marketing Plan will be finalized no later than * * * prior to the planned First Commercial Sale of such Licensed Product in such country.

           5.1.2 Each Marketing Plan will include, at a minimum, projections of the following:* * *.

      5.2 Marketing Activities .

           5.2.1 * * * will prepare in consultation with * * *, and the JCC will review and approve, the following: (i) the programs for training the medical liaison personnel as well as product managers and all marketing and sales force personnel; (ii) the plan for medical marketing activities; (iii) any materials related to: promotion, conferences, conventions, grants, paid speakers, life cycle management, health economic studies, journal & magazine advertisement, website marketing, etc. for the Licensed Product; (iv) annual rolling forecasts of sales, market growth and market share of the Licensed Product; (v) the proposed number of sales representatives, product managers, and medical liaison personnel; and (vi) a proposal for the selection of a public relations and marketing agency to assist in the marketing of Licensed Product.

           5.2.2 * * * will use its Commercially Reasonable Efforts to: (i) * * * (iii) perform a market and positioning study, (iv) with respect to the Angioedema Field* * * ; (v) deploy the sales force and detailing of Licensed Product at the priority established in the Marketing Plans; (vi) * * *; (vii) establish a process for handling returns of defective or expired Licensed Product; (viii) * * * *.

           5.2.3 * * * will use its Commercially Reasonable Efforts, in consultation

          with * * *, to develop the packaging design, and will have the right to visit customers, key opinion leaders, physicians, and patient organizations with * * * and upon no less than two (2) Business Days’ prior notice, * * *.

           5.2.4 * * * : (a) participate in any related launch event, (b) train the product managers, medical liaison personnel as well as the sales representatives involved in the detailing of the Licensed Product in accordance with the training programs approved by the JCC, (c) organize and hold meetings with key opinion leaders and patient organizations, and (d) present at conferences and have conference booths with representatives of both Parties and designed to display the Jerini House Marks and Kos House Marks with equal prominence to the extent such presentation or booth is related to Licensed Products and to the extent of the prominence of Licensed Products at such presentation or booth.

      5.3 Performance.

           5.3.1 Kos will report to Jerini sales in the Territory (a) * * * for the * * * following the First Commercial Sale of the Licensed Product, and (b) on * * * basis for the remainder of the Term. If at any time after the first * * * following the First Commercial Sale of the Licensed Product by Kos or its Affiliate, the sales performance, market growth or market share of Licensed Product in the Angioedema Field in the United States * * * *.

           5.3.2 If (i) * * * implements any or all of the remedial measures outlined in Section 5.3.1 for at least* * *, (ii) such measures do not yield a reasonably acceptable improvement in the performance of Licensed Product in the market, * * *, and (iii) * * *. Promptly after receipt of such notice and prior to the expiration of the sixty (60)-day notice period, the * * * will amend the Marketing Plan for the applicable Licensed Product to * * *: provided , that Jerini will have the right to * * *. As used in this Section 5.3.2, “Major Market Country” means any of the following countries: * * *.

      5.4 Allocation of Commercialization Costs. * * * related to the Commercialization of the Licensed Product in the Licensed Field in accordance with the Marketing Plan, except that * * * own employees engaged in the marketing and promotion of Licensed Product.

      5.5 Branding; Trademarks; Trade Dress; Logos .

           5.5.1 At the request of Jerini, Kos will, to the extent permitted by law and customary to local trade and practice, include one or more Jerini House Marks designated by Jerini (each, a “ Designated Jerini Trademark ”) in relevant information disclosed publicly by Kos relating to this Agreement or a Licensed Product, in the form of Licensed Product-related websites and seminar and conference posters regarding this Agreement or a Licensed Product.

           5.5.2 Unless the Parties otherwise agree, the Product Trademarks for use on or in connection with Licensed Product will be the same as utilized by Jerini outside the Territory.

If any such trademark is unavailable for use in the Territory, Jerini will select, subject to Kos’s consent, alternative Product Trademarks for use on or in connection with Licensed Product. Except as expressly set forth herein, Jerini will be the sole owner of the Product Trademarks. Jerini will be responsible for the filing, prosecution, maintenance and defense of all registrations of the Product Trademarks, and will be responsible for the payment of any costs relating to filing, prosecution, maintenance and defense of the Product Trademarks in the Territory.

           5.5.3 Subject to the provisions of Section 5.5.1 above and except for the use of Kos House Marks, Kos will market, promote, sell and distribute the Licensed Products under the Product Trademarks only, unless the Parties agree otherwise in writing.

           5.5.4 In connection with the use of any Product Trademarks or any Designated Jerini Trademark, Kos will (a) place the appropriate trademark symbol, such as TM or ^® , adjacent to any Product Trademark or Designated Jerini Trademark and (b) not use such Product Trademark or Designated Jerini Trademark in the plural or possessive form. Kos recognizes and agrees that such steps are necessary to protect and enhance the value and goodwill of the Product Trademarks or any Designated Jerini Trademark. Jerini will have the right to review any Licensed Product promotional materials and any labels or packaging materials prepared by or for Kos that bear any Product Trademarks or any Designated Jerini Trademark in order to confirm that such trademarks are being used in all material respects in accordance with the terms of this Section 5.5.4. Any such review will take place within five (5) Business Days of a written request by Kos. In the event Jerini fails to provide a written noti