LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT

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CV THERAPEUTICS INC | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA

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Title: LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT
Governing Law: New York Date: 11/7/2008
Industry: BIOTRX Sector: HEALTH

Search Content License Agreement by:

Exhibit 10.1

LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT

BETWEEN

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA

AND

CV THERAPEUTICS, INC.

[****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions.

TABLE OF CONTENTS


1.0	DEFINITIONS	3

2.0	GOVERNANCE	15

3.0	LICENSES	21

4.0	UP-FRONT FEE, MILESTONES AND ROYALTIES	24

5.0	PAYMENT PROCEDURES AND RECORDS	30

6.0	COMMERCIALIZATION AND DILIGENCE	34

7.0	REGULATORY	40

8.0	SAFETY	43

9.0	MANUFACTURING AND SUPPLY OF PRODUCT	45

10.0	OPTION FOR CVT TO DETAIL THE PRODUCT	47

11.0	PRODUCT DEVELOPMENT	49

12.0	INTELLECTUAL PROPERTY AND INFRINGEMENT	55

13.0	CONFIDENTIALITY	59

14.0	REPRESENTATIONS AND WARRANTIES	61

15.0	INDEMNIFICATION AND INSURANCE	63

16.0	TERM AND TERMINATION	66

17.0	DISPUTE RESOLUTION	70

18.0	MISCELLANEOUS PROVISIONS	71

LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT

This License, Development and Supply Agreement is entered into and made effective as of the 12 ^th day of September, 2008 (“ Effective Date ”) by and between CV Therapeutics, Inc. a Delaware corporation having its principal place of business at 3172 Porter Drive, Palo Alto, California 94304, (“ CVT ”), and Menarini International Operation Luxembourg SA, a Luxembourg corporation, having its principal place of business at 1 Avenue de la Gare, L-1611, Luxembourg GD (“ MIOL ”). CVT and MIOL are each hereafter referred to individually as a “Party” and collectively as the Parties.

WHEREAS , CVT is the owner or exclusive licensee of certain CVT Patent Rights and CVT Know-How relating to the Compound and/or the Product (as such terms are defined below), and the use thereof;

WHEREAS , CVT wishes to grant MIOL rights under such intellectual property seeking a partner for the development and commercialization of the Product in the Territory;

WHEREAS , MIOL wishes to obtain an exclusive license to such CVT Patent Rights and CVT Know-How so that MIOL may assist in the development of, and obtain the rights to Commercialize the Compound in the Territory (as defined below); and

WHEREAS , CVT is willing to grant such a license to MIOL on the terms set forth herein.

NOW, THEREFORE , in consideration of the mutual promises contained herein, the Parties agree as follows:

1.0 DEFINITIONS

The terms defined elsewhere in this Agreement shall have the meanings specified herein. The following terms shall have the following meanings for purposes of this Agreement: Terms defined in the singular shall have the same meaning when used in the plural, and vice versa, unless stated otherwise.

1.1 “Action” shall mean any claim, action, cause of action or suit (whether in contract or tort or otherwise), litigation (whether at law or in equity, whether civil or criminal), controversy, assessment, arbitration, investigation, hearing, charge, complaint, demand, notice or proceeding of, to, from, by or before any Government Authority.

1.2 “Additional Indication” shall have the meaning set forth in Section 11.3(a).

1.3 “Adverse Event, Adverse Drug Reaction, AE or Serious Adverse Event” shall have the meaning set forth in Section 8.1(c).

1.4 “Affiliate” of any Party means any corporation, firm, limited liability company, partnership or other entity which directly or indirectly controls or is controlled by or is under common control with a Party to this Agreement. For purposes of this Section 1.4, “control” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, or status as a general partner in the case of any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body or management of a corporation or other entity.

1.5 “Agreement” shall mean this License, Development and Supply Agreement, including any exhibits or other attachments hereto, as the same may be validly amended by the Parties from time to time.

1.6 “Alliance Manager” shall have the meaning set forth in Section 2.5.

1.7 “CGMP” or “CGMP Regulations” shall mean those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices, including but not limited to EU Directives 2003/94/EC code of GMP and 2001/83/EC as amended by 2004/27/EC code of practice for the QP, and all other relevant EU and UK principles and guidelines, ICH Tripartite Guidance Q7A and guidance documents relating to GMP and GDP as well as applicable US Current Good Manufacturing Practices (21 CFR 210 and 211) that govern the standards of manufacture for any product intended for human use, as appropriate.

1.8 “Combination Product” shall mean any pharmaceutical product that (a) is a fixed dose combination product containing the Compound and one or more other active pharmaceutical compounds and/or active ingredients (a “FDC”), or (b) is any Product packaged and sold together with another pharmaceutical product for a single invoiced price (a “Co-Packaged Product” ).

1.9 “Commercialization” or “Commercialize” shall mean all activities directed to Marketing, Distribution, Detailing, promotion importing, exporting or selling the Product in the Territory during the Term of the Agreement and all activities directed to obtaining Pricing Approvals for the Product in the Territory.

1.10 “Commercial Launch” shall mean that, in any given country in the Territory, both the following conditions have been satisfied in such country: (a) Sales Representatives are conducting Details in the country; and (b) the First Commercial Sale Date has occurred. “Commercial Launch Date” shall mean the first date on which such conditions have been satisfied.

1.11 “Commercially Reasonable Efforts” shall mean [ **** ] . “Commercially Reasonable Efforts” shall be determined on a country-by-country basis for the Product, and shall require that the Party, at a minimum: [ **** ] . In addition, in this Agreement and the Supply Agreement where [ **** ] is obligated to use its best efforts as to specified obligations, the Parties intend and agree that such best efforts is a significantly higher standard of performance than Commercially Reasonable Efforts as defined herein.

1.12 “Compound ” shall mean the racemic form of the chemical substance having the chemical name ( ± )N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazine acetamide (also known by the generic name of ranolazine) including salts thereof. In addition, MIOL has a right of first negotiation in the Territory as set forth in Section 3.5 below.

1.13 “Control” or “Controlled” shall mean, with respect to any intellectual property right or any other intangible property under this Agreement, the possession (whether directly or through an Affiliate) by license or ownership, by a Party of the ability to grant to the other Party access, rights and/or a license or sublicense as provided under this Agreement.

1.14 “Co-Packaged Product” shall have the meaning set forth in Section 1.8(b).

1.15 “CVT Detailing Option” shall have the meaning set forth in Section 10.1(a).

1.16 “CVT Detailing Option Exercise Notice” shall have the meaning set forth in Section 10.1.

1.17 “CVT Independent Development” shall have the meaning set forth in Section 11.4(a).

1.18 “Cover” , “Covering” and “Covered” shall mean, with respect to any Patent Rights under this Agreement that, in the absence of a license granted under a Valid Claim under said Patent Rights, the Development, Manufacture or Commercialization of the Product would infringe such Patent Right.

1.19	“Cure Period” shall have the meaning set forth in Section 16.2.

1.20	“CVT Indemnified Parties” shall have the meaning set forth in Section 15.2(b).

1.21 “CVT Know-How” shall mean any and all Know-How that is controlled by CVT as of the Effective Date or at any time during the Term, that (a) relates to the Compound and/or the Product (including any Know-How licensed to CVT by a Third Party, developed by CVT or to which CVT has otherwise obtained rights under the CVT/Roche Agreement and any Know-How arising in connection with any Phase IV Study conducted by CVT pursuant to the Agreement), and (b) is used in, useful in or necessary for the development, manufacture or commercialization of any Product in the Field in the Territory or is covered by CVT Patent Rights. Notwithstanding the foregoing, CVT Know-How shall not include any Joint Know-How or any MIOL Know-How.

1.22 “CVT Patent Rights” shall mean any and all Patent Rights that are controlled by CVT as of the Effective Date or at any time during the Term (including those Patents licensed to CVT by a Third Party, developed by CVT or to which CVT has otherwise obtained rights under the CVT/Roche Agreement) that Cover the Compound and/or the Product, its use or the manufacture thereof. Notwithstanding the foregoing, CVT Patent Rights shall not include any Joint Patent Rights or MIOL Patent Rights. The CVT Patent Rights as of the Effective Date are set forth on Exhibit A.

1.23 “CVT Projects” shall have the meaning set forth in Section 11.6.

1.24 “CVT/Roche Agreement” shall mean that certain License Agreement between CVT and Roche Palo Alto LLC (successor in interest by merger to Syntex (USA) Inc.), dated March 27, 1996, as amended from time to time.

1.25 “Detail” or “Detailing” shall mean a face-to-face presentation of the Product by a Sales Representative to a medical professional with prescribing authority.

1.26 “Detailing Agreement” shall have the meaning set forth in Section 10.1(c).

1.27 “Development” or “Develop” shall mean all preclinical, non-clinical and clinical research and drug development activities conducted by either Party with respect to the Product or the Compound, and shall include, without limitation, all toxicology, pharmacology and other discovery efforts, test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, any clinical studies (but excluding any Phase IV Studies), all activities relating to such pre-clinical or clinical studies and/or in connection with seeking and/or obtaining any Regulatory Approval for any New Indication (but excluding any activities directed to obtaining any Pricing Approvals). “Development” shall not include any activities that relate to MIOL’s election (if any) to Manufacture and supply Product under Article 9.0, or any activities that relate to Pricing Approvals or Phase IV Studies conducted by CVT or MIOL.

1.28 “Development Agreement” shall have the meaning set forth in Section 11.7.

1.29 “Development Costs” shall mean costs incurred by either Party as calculated in accordance with GAAP or IFRS, as applicable, and with respect to Joint Development only to the extent that such costs are incurred in accordance and consistent with a mutually agreed upon Joint Development Plan and related budget under Article 11.0. “Development Costs” shall include, without limitation: (a) all out-of-pocket costs and expenses incurred including external consultants; (b) the costs of internal personnel engaged in Development efforts, which costs shall be determined by multiplying the time appropriately allocated for the Party’s internal personnel to such Development (in

accordance with GAAP or IFRS) by the then-applicable FTE Rate, unless another basis for determining such internal costs is otherwise agreed upon by the Parties in writing; and (c) the costs and expenses of supplies for pre-clinical and clinical studies set forth in the Joint Development Plan, including costs and expenses of pre-clinical and clinical supplies of the Product and to purchase and/or package comparator or combination drugs or devices and costs and expenses of disposal of clinical supplies. “Development Costs” shall not include costs and expenses of establishing MIOL or any Affiliate of MIOL as a primary or secondary source supplier under Article 9.0, including without limitation, the transfer of process and manufacturing technology and analytical methods, scale up, process and equipment validation, initial manufacturing licenses, approvals and inspections, VAT, import taxes, duties, and any other required taxes.

1.30 “Distribution” or “Distribute” shall mean activities specifically related to distribution or sale of the Product in the Territory during the Term of the Agreement, including, without limitation, order receiving and processing, invoicing and collection, receiving and booking sales, customer services, collection of data of sales to hospitals and other end users, credit, handling returns of the Product, handling, logistics, warehousing, shipping, import, export, distribution, and inventory and receivables.

1.31 “Effective Date” shall have the meaning set forth in the first paragraph of this Agreement.

1.32 “EMEA” shall mean the European Medicines Agency or any successor agency thereto.

1.33 [****] shall have the meaning set forth in Section 3.5(a).

1.34 “EU” shall mean the European Union or any successor thereto, and shall include all countries and jurisdictions as may be added to the European Union from time to time during the Term.

1.35 “European Patent Office” shall mean The European Patent Office or any successor agency thereto.

1.36 “FDA” shall mean the United States Food and Drug Administration or any successor thereto.

1.37 “FDC” shall have the meaning set forth in Section 1.8(a).

1.38 “Field” shall mean any human prescription use(s) where the Compound is the sole active ingredient or is combined with another active ingredient.

1.39 “Firm Offer” shall have the meaning set forth in Section 9.1(d).

1.40 “First Commercial Sale Date” shall mean the date of the first commercial sale of a Product in the Territory by or on behalf of MIOL or any sublicensee or Affiliate of MIOL. “ First Commercial Sale Date ” shall not include the date of any sale of the Product which is for the sole purpose of (a) obtaining Regulatory Approval, (b) compassionate, named patient or similar use, or (c) use for any Phase IV Study or other clinical study.

1.41 “Force Majeure Event” shall have the meaning set forth in Section 16.8.

1.42 “Fourth Detail” or “4° Pos.” shall mean a Detail in which Product information is communicated along with information about other products by a Sales Representative to a physician with the specified content as defined from time to time by the Parties, where the Product information is the fourth product information communicated by the Sales Representative.

1.43 “FTE” shall mean the annual full-time equivalent person year (consisting of a total of 1,800 hours of work) for all personnel involved in Development or other activities under this Agreement.

1.44 “FTE Rate” shall mean the rate of an FTE which shall initially be set at [**** ] dollars ($US [ **** ] ) per FTE, and shall be adjusted in writing by the Parties on the first business day of each calendar year by the annual percentage increase or decrease in the applicable consumer price index.

1.45 “GAAP” shall mean United States generally accepted accounting principles consistently applied by a Party.

1.46 “Governmental Authority” shall mean any federal, national, state, provincial or local government, or political subdivision thereof, or any multinational organization or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body).

1.47 “IFRS” shall mean International Financial Reporting Standards consistently applied by a Party.

1.48 “Indemnified Party” and “Indemnifying Party” shall have the meaning set forth in Section 15.3(a).

1.49 “Initial Indication” shall mean any use as [ **** ] .

1.50 “Joint Development” shall mean Development conducted jointly by CVT and MIOL in accordance with Article 11.0.

1.51 “Joint Development Committee” or “JDC” shall mean a committee established by the Parties in accordance with Section 2.4 to oversee and manage the applicable Law-compliant activities contemplated by the Agreement relating to the Development of the Product under this Agreement.

1.52 “Joint Development Plan” shall mean the written mutually agreed upon detailed written plan(s) for the Parties’ Joint Development efforts under Article 11.0 during the Term, including the mutually agreed upon budgets for Development Costs thereunder. Any “Joint Development Plan” under this Agreement shall be drafted as a timeframe the Parties agree on in writing for the particular Product opportunity with annual rolling plan and budget updates as agreed upon by the Parties in writing. Any “Joint Development Plan” may be amended from time to time during the Term as agreed upon by the Parties in writing as provided in Section 2.4(c)(i).

1.53 “Joint Know-How” shall mean any and all modifications and/or improvements to the CVT Know-How or CVT Patent Rights, solely to the extent that they relate to the Compound and/or the Product, that (a) are used in, useful in or necessary for the Development, Manufacture or Commercialization of any Product in the Territory, and (b) are or have been conceived, reduced to practice, created, developed and/or otherwise invented by or on behalf of CVT or MIOL (i) under any Development Agreement between the Parties, (ii) in connection with any Phase IV Study conducted by MIOL pursuant to the Agreement, or (iii) in connection with any Manufacturing activities which may be conducted by MIOL in the event that MIOL exercises its Manufacturing Option; provided , however , that Joint Know-How shall not include any improvements or modifications to MIOL Know-How and MIOL Patent-Rights, or Know-How that is based on or incorporates MIOL Know-How or MIOL Patent Rights.

1.54 “Joint Operating Committee” or “JOC” shall mean a committee established by the Parties in accordance with Section 2.3 to oversee and manage the applicable Law-compliant activities contemplated by the Agreement relating to the Commercialization of the Product.

1.55 “Joint Patent Rights” shall mean any and all Patent Rights Covering any Joint Know-How. For the avoidance of doubt, Joint Patent Rights shall not include any CVT Patent Rights, MIOL Patent Rights or any Patent Rights Covering any CVT Know-How or MIOL Know-How.

1.56 “Joint Steering Committee” or “JSC” shall mean a committee established by the Parties in accordance with Section 2.2 to oversee, review and manage the applicable Law-compliant activities and obligations of the Parties as set forth in the Agreement.

1.57 “Know-How” shall mean any and all information, data and materials, whether proprietary or not and whether patentable or not, including, without limitation, know how, trade secrets, technology, scientific, medical, clinical, toxicological and technical information, processes and analytical methodology useful in development, formulation, testing, analysis and manufacture, ideas, concepts, formulas, methods, procedures, designs, compositions, plans, documents, data, inventions, discoveries, works of authorship, compounds and biologic materials.

1.58 “Law” shall mean a federal, state or local or foreign or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any government order, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.

1.59 “Losses” shall have the meaning set forth in Section 15.2(a).

1.60 “MAA” shall mean the Regulatory Approval application for the Product in the Initial Indication filed by CVT with the EMEA as well as the Regulatory Approval by EMEA of such application.

1.61 “Major European Country” shall mean any one (1) of the [ **** ] .

1.62 “Manufacturing” or “Manufacture” shall mean all activities directed solely to sourcing of necessary raw materials, producing, processing, primary packaging, labeling, quality assurance testing and release, shipping and storage of the Product for the purposes of Commercialization in the Territory during the Term of the Agreement, whether by or on behalf of CVT or MIOL.

1.63 “Manufacturing Cost” shall mean all of the following: [ **** ] . “Manufacturing Cost” shall not include [ **** ] .

1.64 “Manufacturing Option for Bulk API” and “Manufacturing Option for Tableting” shall have the meanings set forth in Sections 9.3(a) and (b).

1.65 “Market” or “Marketing” shall mean activities of a Party specifically related to marketing, promotion, advertising, professional education, product-related public relations, relationships with opinion leaders and professional societies, market research, health care economic studies, all lobbying and contacts with applicable Regulatory Authorities, Governmental Authorities, purchasing organizations, health care organizations, consumers organizations or other similar bodies in respect of Product pricing and reimbursement and other similar activities relating to the Commercialization of the Product, but for the avoidance of doubt, excluding any activities related to the Detailing or Distribution of the Product.

1.66 “MIOL Indemnified Parties” shall have the meaning set forth in Section 15.2(a).

1.67 “MIOL Know-How” shall mean any and all Know-How that is controlled by MIOL and/or its Affiliates on the Effective Date of the Agreement or at any time during the Term of the Agreement, except for any Know-How to the extent that it (a) relates to the Compound and/or the Product, and (b) was conceived and reduced to practice,

created, developed and/or otherwise invented (i) under any Development Agreement between the Parties, or (ii) in connection with any Phase IV Study conducted by MIOL or CVT pursuant to the Agreement. For the avoidance of doubt, MIOL Know-How does not include any Joint Know-How or any CVT Know-How.

1.68 “MIOL Negotiation Period” and “MIOL Notification Period” shall have the meanings set forth in Section 3.5(b).

1.69 “MIOL Opt-In” and “MIOL Later Opt-in” shall have the meanings set forth in Sections 11.3(a) and (b).

1.70 “MIOL Patent Rights” shall mean any and all Patent Rights that are controlled by MIOL and/or its Affiliates on the Effective Date of the Agreement or at any time during the Term of the Agreement that Cover any MIOL Know-How.

1.71 “MIOL Selected Compounds” shall have the meaning set forth in Section 3.5(b).

1.72 “Net Sales” shall mean, with respect to the Product, the gross invoiced sales of the Product by MIOL, its Affiliates and its sublicensees to non-sublicensee Third Parties, calculated in accordance with GAAP or IFRS (as consistently applied by MIOL to sales of its pharmaceutical products) less the following deductions (also calculated in accordance with GAAP or IFRS) to the extent specifically relating to sales of the Product:

[ **** ]

Sales of Product by and between MIOL and its Affiliates and sublicensees shall not be considered sales to Third Parties and shall be excluded from Net Sales calculations for all purposes. [ **** ] shall be excluded from Net Sales calculations for all purposes. In the event the Product is sold in any country in the Territory as part of a Combination Product, the Net Sales of the Product in such country, for the purposes of determining payments based on Net Sales under this Agreement, shall be adjusted and determined as set forth on Exhibit B to this Agreement.

1.73 “New Indication” shall mean the approval by the [ **** ] , which (a) is not the Initial Indication or a label extension of the Initial Indication, and (b) which includes any indication for the treatment of [ **** ] , or any other new indication which shall be mutually agreed upon as a New Indication in writing by the Parties.

1.74 “Party” shall mean either CVT or MIOL, and “Parties” shall mean CVT and MIOL.

1.75 “Patent Rights” shall mean any and all patents, patent applications, provisional patent applications, substitutions, divisions, continuations, continuations-in-part, non-provisional patent applications converted from provisional patent applications and continued prosecution applications, extensions, reissues, reexaminations, renewals, patents of addition, letters of patent, letters of confirmation or registration, and foreign counterparts thereof or therefore, as well as all supplementary protection certificates and patent term extensions or restorations thereof.

1.76 “Periodic Safety Update Report” or “PSUR” shall mean a report of Adverse Events in the format required by applicable legislation in the applicable Territory prepared and submitted by a Party in respect of the Product on a periodic basis to Regulatory Authorities, and which shall include updates on urgent safety matters or issues, major signal detection and/or evaluation, and changes in efficacy.

1.77 “Permitted Exploitation” and “Non-Permitted Exploitation” shall have the meanings set forth in Section 11.4(a).

1.78 “Phase IV Study” shall mean (a) any study or data collection effort in respect of the Product anywhere in the Territory that is initiated after receipt of Regulatory Approval for the Product and is not intended to support or maintain a Regulatory Approval, maintain a label or otherwise obtain a labeling change, and (b) any study or data collection effort in respect of the Product which is requested, mandated or required by a Governmental Authority for purposes of maintaining the Regulatory Approval of the Product in any country or jurisdiction in the Territory. For purposes of this Agreement, “Phase IV Study” also includes all investigator-initiated studies of the Product in the Territory.

1.79 “Pricing Approvals” shall mean, with respect to any individual country within the Territory, all pricing and reimbursement approvals for the Product from Government Authorities required by applicable Law or Governmental Authorities.

1.80 “Primary Detail for Non-Specialist” or “1° Pos. Non-Specialist” shall mean a Detail in which Product information is communicated along with information about other products by a Sales Representative to a non-specialist physician with the specified content as defined from time to time by the Parties, where the Product information is the first product information communicated by the Sales Representative (and where [ **** ] of the time and emphasis during such communication is focused on the Product [ **** ] ).

1.81 “Primary Detail for Specialist” or “1° Pos. Specialist” shall mean a Detail in which Product information is communicated along with information about other products by a Sales Representative to a specialist physician with the specified content as defined from time to time by the Parties, where the Product information is the first product information communicated by the Sales Representative (and where at least [ **** ] percent ( [ **** ] %) of the time and emphasis during such communication is focused on the Product).

1.82 “Prime Rate” shall have the meaning set forth in Section 5.6.

1.83 “Product” or “Products” shall mean any and all pharmaceutical products for human use, in any delivery method, dosage form or formulation, containing the Compound, whether as a sole active pharmaceutical ingredient or in combination with any other active pharmaceutical ingredient or ingredients.

1.84 “Product Promotional Materials” shall have the meaning set forth in Section 6.3.

1.85 “Regulatory Approval” shall mean the approval of the applicable Regulatory Authority necessary for the Commercialization of the Product for any indication in a country in the Territory. “Regulatory Approval” does not include any Pricing Approvals.

1.86 “Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other Governmental Authority with authority over the marketing and sale of a pharmaceutical product in any country in the Territory, including without limitation, the EMEA in the EU.

1.87 “Residual Royalty” shall have the meaning set forth in Section 4.3(b).

1.88 “Roche” shall mean Roche Palo Alto, LLC, a party to the CVT/Roche Agreement (as successor in interest to Syntex).

1.89 “Safety Agreement” shall have the meaning set forth in Section 8.1(b).

1.90 “Sales Representative” shall mean an individual who engages in or manages Details and other promotional efforts with respect to the Product and who is employed by MIOL or its sublicensees or Affiliates.

1.91 “SEC” shall mean the United States Securities and Exchange Commission or any successor agency thereto.

1.92 “Secondary Detail for Non-Specialist” or “2° Pos. Non-Specialist” shall mean a Detail in which Product information is communicated along with information regarding other products by a Sales Representative to a non-specialist physician with the specified content as defined from time to time by the Parties, where the Product information is the second product information communicated by the Sales Representative (and where [ **** ] of the time and emphasis during such communication is focused on the Product [ **** ] ).

1.93 “Secondary Detail for Specialist” or “2° Pos. Specialist” shall mean a Detail in which Product information is communicated along with information regarding other products by a Sales Representative to a specialist physician with the specified content as defined from time to time by the Parties, where the Product information is the second product information communicated by the Sales Representative (and where at least [ **** ] percent ( [ **** ] %) of the time and emphasis during such communication is focused on the Product).

1.94 “Shortfall Amount” shall have the meaning set forth in Section 6.1(c).

1.95 “Sublicensed Patent Rights” shall have the meaning set forth in Section 12.2(b).

1.96 “Supply Agreement” shall have the meaning set forth in Section 9.1(a).

1.97 “Syntex” shall mean Syntex (USA) Inc, the entity to which Roche is a successor in interest under the CVT/Roche Agreement.

1.98 “Tax” and “Taxes” shall have the meaning set forth in Section 5.3(b).

1.99 “Term” shall have the meaning set forth in Section 16.1.

1.100 “Territory” shall mean Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy (including the San Marino Republic and Vatican City), Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, the United Kingdom, Spain, Sweden, Iceland, Switzerland, Turkey, Macedonia, Croatia, Albania, Bosnia Herzegovina, Liechtenstein, Macedonia, Monaco, Montenegro, Norway, Serbia, Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kirghizstan, Moldova, Tajikistan, Turkmenistan, Ukraine, Uzbekistan, Georgia, Argentina, Brazil, Guatemala, El Salvador, Honduras, Nicaragua, Panama, Costa Rica, Belize, the Dominican Republic, Colombia, Venezuela, Chile, Peru, Paraguay, and Uruguay.

1.101 “Third Detail” or “3° Pos.” shall mean a Detail in which Product information is communicated along with information regarding other products by a Sales Representative to a physician with the specified content as defined from time to time by the Parties, where the Product information is the third product information communicated by the Sales Representative.

1.102 “Third Party” shall mean any party other than CVT or MIOL or an Affiliate of a Party.

1.103 “Third Party License” shall have the meaning set forth in Section 4.5(a).

1.104 “Trademarks” shall mean the Ranexa ^® and Latixa ^® trademarks, and any other trademark(s) which the Parties may mutually agree from time to time should be used instead of Ranexa ^® in any country in the Territory.

1.105 “Valid Claim” shall mean (a) any claim in an issued, unexpired patent of the CVT Patent Rights that (i) has not been cancelled, withdrawn, abandoned, disclaimed, denied or rejected by any administrative agency or other body of competent jurisdiction; and (ii) has not been revoked, held or admitted to be invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal; and (iii) has not been rendered unenforceable through disclaimer or otherwise; and (iv) has not been lost through an interference proceeding; and (v) provides enforceable rights with respect to the exclusive sale of the Product in the Territory; or (b) any claim in any pending application of CVT Patent Rights which (i) has neither been abandoned nor been pending for more than five (5) years and (ii) would provide rights with respect to the exclusive sale of the Product in the Territory if it should issue; or (c) with respect to the Product, any applicable marketing, data protection or other exclusivity provision for the Product under applicable Law anywhere in the Territory.

1.106 “VAT” shall mean value-added tax.

2.0 GOVERNANCE

2.1 Generally . Subject to the other provisions of this Agreement, the Parties agree that the principal objectives of this Agreement are the Development and Commercialization of the Product, including support for obtaining Regulatory Approval of the Product in the Territory. The Parties agree that they shall establish a formal framework within which they will discuss strategies for Development and Commercialization activities for the Product in the Territory.

2.2 Joint Steering Committee.

(a) Procedures . The formal framework referred to in Section 2.1 shall be headed by a Joint Steering Committee as defined herein with such subcommittees as the JSC may establish from time to time as it deems appropriate, including but not limited to standing committees for Development and Commercialization as more fully described herein. Within thirty (30) days after the Effective Date, the Parties will establish a Joint Steering Committee, to oversee those activities and obligations of the Parties under the Agreement as set forth herein and ensure an optimal coordination between the Parties with respect to such activities and obligations. The activities to be performed by the JSC shall solely relate to governance under the Agreement and shall not involve delivery of services. The JSC will be composed of at least two (2) senior level representatives each from CVT and MIOL. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. During the Term, from the Effective Date until the first anniversary of the Effective Date, the JSC will be chaired by a senior executive of CVT and thereafter the chair of the JSC shall rotate on an annual basis between CVT and MIOL on each anniversary of the Effective Date. The chair will be responsible for scheduling and calling meetings and for preparing the agenda for each meeting of the JSC, which agenda shall be distributed to JSC members together with all meeting materials prior to any scheduled meeting. Further procedures for operation of

the JSC shall be decided by the JSC during their first meeting, which must be held at the latest within thirty (30) days from the Effective Date. During such meeting the JSC shall mutually agree, in writing, on the method for determination timing, frequency and location of meetings and methods and deadlines for distribution of materials and agendas. Meetings will be held in person, through telephone or video conference or other mutually agreeable means. Either Party may designate one or more substitutes to temporarily attend and perform the functions of one or more of such Party’s members at any JSC meeting. Other non-member representatives of the Parties may attend JSC meetings. Each Party shall bear its own travel and personnel costs and expenses related to JSC meetings. The JSC shall keep minutes of its meetings that record, in reasonable detail, all decisions and all actions recommended or taken. Drafts of the minutes shall be prepared and circulated by the JSC chair to the members of the JSC within a reasonable time after the meeting, and shall be reviewed, approved and/or revised as necessary prior to the next JSC meeting. Upon approval, final minutes of each meeting shall be circulated to the members of the JSC by the chair.

(b) Consensus; Dispute Resolution . The Parties will strive for good faith consensus wherever possible and will resort to sole decision-making (where authorized under this Agreement) or dispute resolution escalation (where authorized under this Agreement) only after good faith efforts to break a deadlock have failed. Each Party will have one (1) vote on the JSC. If the JSC is unable to resolve a matter that is not within one Party’s express unilateral decision-making authority under this Agreement, such matter shall be forwarded for attempted resolution by good faith negotiations in accordance with the dispute resolution procedures set forth in Article 17.0.

(c) Scope of the JSC . Subject to the other provisions of this Agreement (including this Article 2.0 and Article 17.0), the JSC will have authority for reviewing MIOL’s activities under this Agreement, including those pertaining to Commercialization, Regulatory and safety, Development and Phase IV Studies, including the following scope of authority:

(i) establishing a strategy for Commercialization and Development of the Product in the Territory and overseeing the implementation of such strategy;

(ii) reviewing and approving all plans, programs, proposals and budgets submitted by the JDC and JOC pursuant to Sections 2.3 and 2.4 and Article 11.0, including without limitation Joint Development Plans, Phase IV Studies, Marketing Plans and any material amendments thereto;

(iii) [ **** ] ;

(iv) [ **** ] ;

(v) achieving communication, collaboration, coordination and clarity between the Parties relating to all material activities of the Parties under the Agreement;

(vi) overseeing the governance structure for and activities of other committees contemplated by this Agreement, including overseeing the establishment and organization of the standing JOC and JDC and any other committees organized by the Parties pursuant to this Agreement from time to time during the Term, and each such committee shall be subject to the oversight of the JSC. If any committee established under this Agreement is not constituted or continued, any reference to such committee in this Agreement shall be deemed to be a reference to the JSC or such other committee to which the JSC may delegate responsibility in writing;

(vii) performing such other functions as are appropriate to further the purposes of this Agreement as determined by the Parties in writing from time to time; and

(viii) The JSC shall use good faith efforts to achieve consensus on all matters and shall attempt to settle disputes that are unresolved by the JOC or the JDC; provided , however , that if a dispute is not resolved within [ **** ] days by the JSC, such dispute shall be subject to the procedures set forth in Section 17.2.

It is understood between the Parties that under no circumstance, the activities to be performed by the JSC are intended or allowed to violate any applicable Law (including but not limited to any concurrence and/or antitrust Law).

2.3 Joint Operating Committee.

(a) Procedures . Within thirty (30) days after the Effective Date, the Parties will establish a Joint Operating Committee as defined herein, to oversee those activities and obligations of the Parties under the Agreement as set forth herein and ensure an optimal coordination between the Parties with respect to such activities and obligations. The activities to be performed by the JOC shall solely relate to governance under the Agreement and shall not involve delivery of services. The JOC will be composed of at least two (2) senior level representatives each from CVT and MIOL. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. The JOC will be chaired by a senior commercial manager of MIOL. The chair will be responsible for scheduling and calling meetings and for preparing the agenda for each meeting of the JOC, which agenda shall be distributed to JOC members together with all meeting materials prior to any scheduled meeting. Further procedures for operation of the JOC shall be decided by the JOC during their first meeting, which must be held at the latest within thirty (30) days from the Effective Date. During such meeting the JOC shall mutually agree, in writing, on the method for determination timing, frequency and location of meetings and methods and deadlines for distribution of materials and agendas. Meetings will be held in person, through telephone or video conference or other mutually agreeable means. Either Party may designate one or more substitutes to temporarily

attend and perform the functions of one or more of such Party’s members at any JSC meeting. Other non-member representatives of the Parties may attend JOC meetings. Each Party shall bear its own travel and personnel costs and expenses related to JOC meetings. The JOC shall keep minutes of its meetings that record, in reasonable detail, all decisions and all actions recommended or taken. Drafts of the minutes shall be prepared and circulated by the JOC chair to the members of the JOC within a reasonable time after the meeting, and shall be reviewed, approved and/or revised as necessary prior to the next JOC meeting. Upon approval, final minutes of each meeting shall be circulated to the members of the JOC by the chair.

(b) Consensus; Dispute Resolution . The Parties will strive for good faith consensus wherever possible and will resort to sole decision-making (where authorized under this Agreement) or dispute resolution escalation (where authorized under this Agreement) only after good faith efforts to break a deadlock have failed. Each Party will have one (1) vote on the JOC. If the JOC is unable to resolve a matter within the scope of the JOC, such matter shall be submitted to the JSC for good faith discussion and attempted resolution under Section 2.2(b). If the Parties are unable to resolve such matter at the JSC, such matter shall be forwarded for good faith discussion and attempted resolution in accordance with the dispute resolution procedures set forth in Article 17.0. In the event consensus cannot be achieved after such escalation, MIOL shall have the final vote for all Commercialization issues in the Territory.

(c) Scope of the JOC . Subject to the other provisions of this Agreement (including this Article 2.0 and Article 17.0), the JOC will have responsibility for reviewing and developing a plan for the overall Product strategy, including without limitation, the following scope of authority:

(i) reviewing information to be provided by MIOL as set forth in Section 6.2 of the Agreement;

(ii) ensuring that the Commercialization of the Product be in compliance with [ **** ] ;

(iii) [ **** ] ;

(iv) reviewing and recommending to the JSC the forecast for commercial supply of the Product in the Territory;

(v) [ **** ] ;

(vi) upon any exercise by CVT of the CVT Detailing Option under Section 10.1, revising the Marketing plan in accordance with Section 6.2(c) and submitting such revised Marketing plan to the JSC for approval as provided in Section 2.2(c)(ii), and discussing in good faith any concerns MIOL may have regarding any sales personnel provided by CVT through a contract sales organization, if any, in connection with such CVT Detailing Option; and

(vii) providing regular updates to the JSC regarding activities within the purview of the JOC.

It is understood between the Parties that under no circumstance, the activities to be performed by the JOC are intended or allowed to violate any applicable Law (including but not limited to any concurrence and/or antitrust laws).

2.4 Joint Development Committee.

(a) Procedures . Within thirty (30) days after the Effective D

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