COLLABORATION AGREEMENT BY AND BETWEEN PHARMACYCLICS, INC., AND LES LABORATOIRES SERVIER AND INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

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Title: COLLABORATION AGREEMENT BY AND BETWEEN PHARMACYCLICS, INC., AND LES LABORATOIRES SERVIER AND INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Governing Law: Delaware Date: 9/22/2009
Industry: Biotechnology and Drugs Sector: Healthcare

Exhibit 10.83

COLLABORATION AGREEMENT

BY AND BETWEEN

PHARMACYCLICS, INC.,

AND

LES LABORATOIRES SERVIER

AND

INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

April 16, 2009

*** Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

SUMMARY

RECITALS

Article 1 - DEFINITIONS

Article 2 - MANAGEMENT OF THE COLLABORATION

Article 3- RESEARCH PROGRAM

Article 4- DEVELOPMENT, REGISTRATION AND COMMERCIALIZATION

Article 5 - FINANCIAL TERMS

Article 6 - LICENSES

Article 7 - INTELLECTUAL PROPERTY

Article 8 - CONFIDENTIALITY

Article 9 - REPRESENTATIONS, WARRANTIES AND COVENANTS

Article 10 - INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY

Article 11 - TERM AND TERMINATION

Article 12 - GOVERNING LAW AND DISPUTE RESOLUTION

Article 13 - GENERAL PROVISIONS

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COLLABORATION AGREEMENT

THIS COLLABORATION AGREEMENT (the " Agreement ") is made effective as of April 16, 2009 (the "Effective Date") by and between Pharmacyclics, Inc., a corporation organized under the laws of the State of Delaware, having offices at 995 East Arques Avenue, Sunnyvale, California 94085, United States of America, (" Pharmacyclics "),and Les Laboratoires Servier , a company organized under the laws of France, having offices at 22 rue Garnier, 92200 Neuilly sur Seine Cedex, France (" Servier ") and Institut de Recherches Internationales Servier, a company organized under the laws of France, having offices at 6, Place des Pléiades, 92415 Courbevoie. Pharmacyclics and Servier are sometimes referred to herein individually as a " Party " and collectively as the " Parties ."

RECITALS

WHEREAS, Pharmacyclics is developing novel small molecule Pan-HDAC Inhibitors (as defined below), including without limitation intravenous and oral formulations of a certain clinical lead compound and a certain backup compound;

WHEREAS, Servier is a global company devoted to discovering, developing, manufacturing and marketing human pharmaceutical products;

WHEREAS, Pharmacyclics owns or has rights under certain patents, patent applications, other valuable technology and pre- clinical know-how relating to small molecule Pan-HDAC Inhibitors, and may develop or acquire additional related rights;

WHEREAS, Pharmacyclics and Servier share a mutual interest in a collaboration aimed at further research and development of Pan-HDAC Inhibitors back-up compounds;

WHEREAS, Servier desires to further , develop, register and commercialize the Pan-HDAC Inhibitors in the Territory (as defined below), and Pharmacyclics desires to have the Pan-HDAC Inhibitors , developed, registered and commercialized in the Territory, in accordance with this Agreement;

WHEREAS, Servier desires to obtain from Pharmacyclics certain exclusive rights and licences for the Pan-HDAC Inhibitors, and Pharmacyclics is willing to grant to Servier such rights and licences on the terms and conditions set forth below;

WHEREAS, Pharmacyclics is willing to grant to Servier an exclusive option to obtain the right to develop, register and commercialize the Option Compounds (as defined below) in the Territory.

In consideration of the premises and of the mutual covenants and obligations set forth herein, the Parties hereby agree as set out below.

ARTICLE 1
DEFINITIONS

The following capitalized terms shall have the following meanings:

1.1 "Active Component " means any product other than a Licensed Product that performs an identifiable prophylaxis, treatment, amelioration or maintenance function when combined with a Licensed Product.

1.2 "Agreement " shall have the meaning set forth in the first paragraph of this Agreement.

1.3 "Affiliate " means a Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with Servier or Pharmacyclics. For purposes of this definition, "control" means the possession, direct or indirect, of the power to

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cause the direction of the management and policies of a Person, whether through ownership of fifty percent (50%) or more of the voting securities of such Person, by contract or otherwise

1.4 "Applicable Laws " means all laws, statutes, ordinances, codes, rules and regulations that have been enacted by a Government Authority and are in force as of the Effective Date or come into force during the Term, in each case to the extent that the same are applicable to the performance by the Parties of their respective obligations under this Agreement.

1.5 "Approval Application " means any application necessary and appropriate to obtain a Regulatory Approval, together with all required documents, data and information concerning any Licensed Product that is the subject of such application.

1.6 "Back-Up Compound(s)" means any Pan-HDAC Inhibitor, other than the Initial Compound and the Initial Back- Up Compound, selected by the JRDC or Servier to replace the Initial Compound or the Initial Back-up Compound as a Collaboration Compound or a Licensed Product. The Back-up Compounds may be identified within the frame of the Research Program.

1.7 "Biomarker " means a biochemical feature, such as a change in a signaling pathway or the expression level of a protein that can be used to measure the progress of disease or the effects of a treatment. For purposes of illustration, but not limitation, a Biomarker may be one or more proteins or mRNA or DNA that (a) reflect drug exposure (for example, a pharmacodynamic biomarker), (b) are a surrogate of an effective outcome (for example, a pharmacoefficacy biomarker) and/or (c) are a predictor as to whether an individual patient will respond to treatment (for example, a predictive biomarker).

1.8 "Bulk Form " means (a) bulk active pharmaceutical ingredient or (b) any pharmaceutical ingredient that as sold cannot be used or distributed without further processing, combination with other Active Components or inactive components or packaging into Dosage Form.

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1.9 "Business Day " means any day (other than Saturday, Sunday or federal or state legal holiday) on which banking institutions are open for business in New York, New York, USA, and Paris, France.

1.10 "Calendar Quarter " means for each Calendar Year, each of the three month periods ending March 31, June 30, September 30 and December 31; provided, however, that (a) the first Calendar Quarter of any particular period shall extend from the commencement of such period to the end of the first complete Calendar Quarter thereafter; and (b) the last Calendar Quarter shall end upon the expiration or termination of this Agreement.

1.11 "Calendar Year " means, for the first Calendar Year, the period beginning on the Effective Date and ending December 31, 2009, and for each Calendar Year thereafter, each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31; provided, however, that the last Calendar Year of the Term will be the period beginning on January 1 and ending on the effective date of expiration or termination of the Agreement Term.

1.12 "Collaboration " means all activities by and obligations of the Parties under this Agreement.

1.13 "Collaboration Compound(s) " means the Initial Compound, the Initial Back-Up Compound and any and all Back-Up Compounds.

1.14 "Combination Product " means a product that contains a Licensed Product and one (1) or more Active Components.

1.15 "Competitive Compound " shall have the meaning set forth in Section 6.3.1

1.16 "Confidential Information " shall have the meaning set forth in Section 8.1.

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1.17 "Contract Year " means each one (1) year period beginning on the Effective Date or each anniversary thereof.

1.18 "Control " means, with respect to item, intellectual property, or other information, that the Party named as having Control (or an Affiliate controlled by such Party) owns such item, intellectual property, or other information, or otherwise possesses the ability to grant a license or sublicense under such intellectual property without violating the terms of any agreement or other arrangement with a Third Party.

1.19 "Data " means all preclinical data, clinical data, CMC data, clinical pharmacology data, research data, Manufacturing data and all regulatory documentation and filings and Regulatory Approvals submitted or obtained in or outside the Territory together with its supporting data and regulatory correspondence and rights to reference the same, in each case pertaining to any Collaboration Compound or Licensed Product, which are Controlled by each Party at any time during the Term of this Agreement.

1.20 "Development Plan " shall have the meaning set forth in Section 4.1.2.

1.21 "Disclosing Party " shall have the meaning set forth in Section 8.1.

1.22 "DMF " shall have the meaning set forth in Section 4.2

1.23 "Dollars " or " $ " means the lawful currency of the United States of America.

1.24 "Dosage Form " means a pharmaceutical product that as sold is in individual dosage amounts and in the form approved for clinical supply or for sale to end users.

1.25 "Effective Date " shall have the meaning set forth in the first paragraph of this Agreement.

1.26 "EMEA " means the European Medicines Agency, and any successor thereto.

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1.27 "FDA " means the United States Food and Drug Administration, and any successor thereto.

1.28 "Field " means the prophylaxis, treatment, amelioration, and maintenance of human diseases.

1.29 "First Commercial Sale " means the first sale of a Licensed Product by Servier, its Affiliates or its Sublicensees (including without limitation any of its co-marketing partners) for use or consumption of such Licensed Product in a country where Regulatory Approval of such Licensed Product has been obtained, or otherwise permitted for sale by the Governmental Authority of such country. Sale of a Licensed Product by Servier to an Affiliate of Servier or a Sublicensee of Servier shall not constitute a First Commercial Sale unless such Affiliate or such Sublicensee is the end user of the Licensed Product; provided, however, that in no event shall any sales for premarketing, testing or sampling be deemed a First Commercial Sale.

1.30 "Fully Burdened Cost of Goods of Manufacturing " means, as applicable:

1.30.1 "Fully Burdened Cost of Goods of Manufacturing Bulk Form" as such term is defined in Exhibit 1.32(a); and

1.30.2 "Fully Burdened Cost of Goods of Manufacturing Dosage Form" as such term is defined in 1.32(b).

1.31 "GAAP " means U.S. Generally Accepted Accounting Principles, consistently applied.

1.32 "GLP " means the regulations set forth in 21 C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the United States.

1.33 "Government Authority " means any supranational, national, regional, state or local government, court, governmental agency, authority, board, bureau, instrumentality or regulatory

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body, including without limitation any national (e.g., the FDA or the MHLW), supranational (e.g., the EMEA), regional, state or local regulatory agency, department bureau, commission, council or other government entity in any jurisdiction of the world that has responsibility for granting any licenses or approvals or granting pricing and/or reimbursement approvals necessary for the marketing and sale of a pharmaceutical product in any country.

1.34 [***]

1.35 "Improvement(s) " means any future new or useful discovery, invention, contribution, finding, or improvement that is generally applicable to the Collaboration Compounds and / or Licensed Products, the Manufacture, design, testing use or formulation thereof, whether or not patentable, and all related Know-How, that is conceived and reduced to practice by Pharmacyclics and/or Servier (or their Affiliates exercising rights under this Agreement) under this Agreement, either solely or jointly.

1.36 "IND " shall mean an Investigational New Drug application filed with FDA or a similar application filed with an applicable Governmental Authority outside of the United States such as a clinical trial application (CTA).

1.37 "Infringement " shall have the meaning set forth in Section 7.4.1.

1.38 "Initial Back-Up Compound " means [***].

1.39 "Initial Compound " means the Pan-HDAC Inhibitor known as PCI-24781, having the structure shown in Exhibit 1.7.

1.40 "Inspected Party " shall have the meaning set forth in Section 4.7.

1.41 "Joint Invention " means any invention, development, or discovery, whether or not patentable, pertaining to a Collaboration Compound or a Licensed Product, conceived and reduced to practice during the course of performance under this Agreement jointly by (a) employees or

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agents of Pharmacyclics or any of its Affiliates and (b) employees or agents of Servier or any of its Affiliates.

1.42 "Joint Patents " means (a) all patent applications that claim Joint Inventions and that are filed by or for the behalf of Pharmacyclics and Servier or an Affiliate of either pursuant to Section 7.3; (b) all patent applications that claim Improvements with respect to Joint Inventions; (c) all divisional, continuation, continuation-in-part or substitute applications which claim priority from any of the patent applications within (a) or (b) above; and (d) all patents which may issue on any of the patent applications within (a), (b) or (c) above, and all extensions, reexaminations or re-issues of any of such patents.

1.43 "JNDA " means a marketing authorization application filed with the MHLW

1.44 "Know-How " means information, data (including Data) and proprietary rights of any type whatsoever (other than Patent Rights and trademarks) in any tangible or intangible form whatsoever, including, without limitation, inventions, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data and other similar information.

1.45 "Licensed Product(s) " means any pharmaceutical preparation in final form (or, where the context so indicates, the form under development) containing a Collaboration Compound as a primary active therapeutic ingredient for use in the Territory.

1.46 "Losses " shall have the meaning set forth in Section 10.1.

1.47 "MAA " shall mean a marketing authorization application filed with the EMEA pursuant to the centralized approval procedure in Europe or to national approval procedure with the applicable Governmental Authority of a country of the Territory outside Europe.

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1.48 "Manufacturing " or " Manufacture " shall mean activities directed to producing, manufacturing, processing, filling, finishing, packaging, labeling, quality assurance testing and release, shipping and storage of a product.

1.49 "MHLW " means the Ministry of Health, Labor and Welfare, otherwise referred to as "Koseisho," or any successor thereto, which governs the review of human pharmaceutical products in Japan.

1.50 "NDA " shall mean a New Drug Application pursuant to Section 505 of the United States Federal Food, Drug and Cosmetic Act (21 U.S.C. Section 355) and the regulations promulgated thereunder related to a Product submitted to the FDA or any successor application.

1.51 "Negotiation Period " shall have the meaning set forth in Section 3.2.2.

1.52 "Net Sales " means: [***]

1.53 "Option " shall have the meaning set forth in Section 3.2.1.

1.54 "Option Compound(s) " means any compound developed by Pharmacyclics prior or during the Research Term:

1.54.1 that comprises

a. an [***] Inhibitor or

b. an active ingredient of which is a small molecule and the mechanism of action of which is solely as an inhibitor of [***];

1.54.2 that is not the Initial Compound, the Initial Back-Up Compound or any Back-Up Compound(s).

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1.55 "Option Compound License Agreement " shall have the meaning set forth in Section 3.2.2

1.56 "Pan-HDAC Inhibitor " means a small molecule that inhibits the enzymatic activity of all active isoforms of histone deacetylase with similar potency, but not including any [***]-[***], including, for example, [***] [***].

1.57 "Party " or " Parties " shall have the meaning set forth in the first paragraph of this Agreement.

1.58 "Patents" means all patents and patent applications, and all continuing and divisional patent applications, continuations-in-part and reissue applications claiming priority, indirectly and directly, to such applications, and all patents issuing therefrom in the relevant Territory as well as any patent term extensions.

1.59 "Patent Costs " means all reasonable out of pocket fees and expenses, actually incurred in connection with the establishment and maintenance of rights under the Patent Rights, including without limitation, the official fees and reasonable patent attorneys' fees associated with the preparing, filing, prosecuting (including translation fees) and maintenance of such patent applications and patents, the costs of conducting re-examinations, reissues, requests for patent term extensions and the like with respect to such patents, and the costs associated with the conduct of interferences, the defense of oppositions and other similar proceedings in the Territory with respect to any such patent applications and/or patents.

1.60 "Patent Rights " means (a) patent applications and patents Controlled by a Party or the Parties at any time during the Term relating to the subject matter of this Agreement, including without limitation patent applications and patents with respect to Improvements; (b) all divisional, continuation, continuation-in-part or substitute applications which claim priority from any of the

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patent applications within (a) above; (c) all patents that may issue on any of the patent applications within (a) or (b) above; (d) all extensions, re-examinations, or reissues of patents within (a) or (c) above.

1.61 "Person " means any person or legal entity.

1.62 "Pharmacyclics " shall have the meaning set forth in the first paragraph of this Agreement.

1.63 "Pharmacyclics Biomarker " means a Biomarker Controlled by Pharmacyclics which is necessary or useful for clinical development and/or commercialization (e.g., [***] Biomarker) of a Pan-HDAC Inhibitor.

1.64 "Pharmacyclics Know-How " means Know-How Controlled by Pharmacyclics that is necessary or useful to Manufacture, have Manufactured, use, sell, have sold, import and export Licensed Products.

1.65 "Pharmacyclics IP " shall have the meaning set forth in Section 7.1.1.

1.66 "Pharmacyclics Patent Rights " means any Patent Right controlled by Pharmacyclics before or during the Term (including Pharmacyclics interests in Joint Patents) and necessary or useful to Manufacture, have Manufactured, use, have used, sell, have sold, import and export Licensed Product and Combination Product including but not limited to the Patent Rights listed in Exhibit 1.66.

1.67 "Phase II Clinical Trial " means a human clinical trial of a Licensed Product conducted for purposes of preliminary determination of efficacy and/or preliminary establishment of appropriate dosage ranges for efficacy and safety in patients as described under 21 C.F.R. 312.21(b) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study.

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1.68 "Phase III Clinical Trial " means any clinical study intended as a pivotal study for purposes of seeking Regulatory Approval that is conducted on sufficient numbers of human subjects to establish that the Licensed Product is safe and efficacious for its intended use, to define warnings, precautions, and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed, and to support Regulatory Approval of the Licensed Product or label expansion of such pharmaceutical product, or a similar clinical study prescribed by the Governmental Authorities in a foreign country. The term "Phase III Clinical Trial" shall include without limitation any clinical trial that would satisfy requirements of 21 C.F.R. 312.21(c), whether or not it is designated a Phase III Clinical Trial.

1.69 "Product Materials " shall have the meaning set forth in Section 11.6.2.

1.70 "Reasonable Efforts " means the level of efforts and resources required to actively develop, register and commercialize a Licensed Product in a sustained manner consistent with the efforts a similarly situated company would typically devote to a product directed to a market of similar size.

1.71 "Receiving Party " shall have the meaning set forth in Section 8.1.

1.72 "Regulatory Approval " means, with respect to a nation or, where applicable, a multinational jurisdiction, any approvals, licenses, registrations or authorizations necessary for the manufacture, marketing and sale of a Licensed Product or Combination Product in such nation or such jurisdiction.

1.73 "Research Plan " shall have the meaning set forth in Section 3.1.

1.74 "Research Program " shall have the meaning set forth in Section 3.1.

1.75 "Research Term " means the period commencing on the Effective Date and expiring on the [***] anniversary thereof, unless extended by the Parties in accordance with Section 3.4.

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1.76 "Research Work " means the research work to be conducted by the Pharmacyclics under the Research Program during the Research Term

1.77 "Responsible Executive " means the President of Pharmacyclics or a duly authorized officer of Servier, or an executive officer of a Party designated by such Party with authority to bind such Party.

1.78 "Servier " shall have the meaning set forth in the first paragraph of this Agreement.

1.79 "Servier IP " shall have the meaning set forth in Section 7.1.2.

1.80 "Servier Know-How " means Know-How Controlled by Servier that is necessary or useful to Manufacture, have Manufactured, use, sell, have sold, import and export Licensed Products.

1.81 "Servier Patent Rights " means any Patent Right Controlled by Servier before or during the Term and necessary or useful to Manufacture, have Manufactured, use, sell, have sold, import and export Licensed Products, including Servier's interest in Joint Patents.

1.82 "Sublicensee " means with respect to a particular Licensed Product or Combination Product, a Third Party to whom Servier has granted directly or indirectly (i) a license to make and sell such Licensed Product or Combination Product, or (ii) a right or license to market, promote or distribute such Licensed Product, provided that such Third Party is responsible for some or all of the marketing or promotion of such Licensed Product or Combination Product within such Third Party's portion of the Territory.

1.83 "Term " shall have the meaning set forth in Section 11.1.1.

1.84 "Territory " means all territories and countries throughout the world, except the United States and its territories and possessions.

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1.85 "Territory-specific Patents " shall have the meaning set forth in Section 7.3.1.

1.86 "Third Party " means any Person other than Pharmacyclics or Servier or their respective Affiliates.

1.87 ""Third Party Technology " shall have the meaning set forth in Section 6.1.4.

1.88 "Valid Claim " means with respect to Pharmacyclics Patent Rights (a) any claim of an issued, unexpired patent that has not been held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction following exhaustion (or expiration) of all possible appeal processes, and that has not been admitted to be invalid or unenforceable through reissue, reexamination or disclaimer or has not been made unenforceable due to a failure to pay maintenance fees, or (b) any composition of matter, article of manufacture or method of use claim contained in an application for a patent that has been pending for less than [***] years.

ARTICLE 2
MANAGEMENT OF THE COLLABORATION

2.1 Joint Research and Development Committee ("JRDC")

2.1.1 Formation and Purpose . Within fifteen (15) Business Days after the Effective Date, Servier and Pharmacyclics shall establish the JRDC, which shall facilitate communication between the Parties by providing a forum for review and discussion of each Party's activities under this Agreement and by coordinating the exchange of Data and other information contemplated in this Agreement. Each party shall designate four (4) representatives to serve as members of the JRDC. Each Party may replace any or all of its JRDC representatives at any time upon written notice to the other Party.

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2.1.2 Meetings . The JDRC shall meet at least twice a year during the Term, unless otherwise agreed by the Parties. Such meetings may be in person or via telephone or video conference or other mutually agreeable means. With the consent of the JDRC members, other representatives of Servier or Pharmacyclics may attend JDRC meetings as ad hoc members. Each Party shall bear its own personnel and travel costs and expenses relating to JDRC meetings.

2.1.3 Specific Responsibilities of the JDRC . In support of its function of facilitating communication between the Parties, the JRDC shall, in particular:

a. review and discuss the Research program, and the Research Plan and the Development Plan , the pivotal clinical protocols, the regulatory strategies, as well as modifications and updates of the Plans ;

b. provide a forum for the review of progress and exchange of ideas and suggestions regarding the development, the registration and commercialization of Licensed Products both inside and outside the Territory ;

c. coordinate the exchange of Data between the Parties;

d. review and discuss the data and results generated under the Research Program;

e. maintain a list of all Option Compounds identified by Pharmacyclics ; and perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.

ARTICLE 3
RESEARCH PROGRAM

3.1 Scope of Research

During the Research Term, Pharmacyclics shall engage in the research activities indicated in the Research Program listed in Exhibit 3.1 (the " Research

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Program "). Pharmacyclics will set forth the activities to be conducted under the Research Program in a research plan, which may be amended from time to time by the Parties (the " Research Plan "). Pharmacyclics will provide results of the Research Program as soon as practicable to benefit ongoing research and/or clinical development on the Initial Compound, the Initial Back-Up Compound and/or the Back-up Compounds, or facilitate selection of an Option Compound and will present a report on its research results on a [***] basis to the JRDC.

3.2 Evaluation of Option Compounds ; Option Exercise

3.2.1 Option Exercise . Pharmacyclics will notify Servier when it identifies an Option Compound under or outside the Research Program during the Term, and provide a written description of such Option Compound. Such notice will include, but not be limited to the chemical structure of any new chemical entity; synthesis and characterization, in vitro panel, and preliminary safety and efficacy data sufficient to support initiation of IND enabling studies. Servier shall have an option with respect to each such Option Compound to obtain a royalty-bearing, exclusive, sublicensable right and license under the Pharmacyclics IP to develop, register and commercialize such Option Compound in the Territory in the Field (each such option, an " Option "). Each such Option shall be exercisable for [***] after delivery of such notice upon written notice to Pharmacyclics.

3.2.2 License Negotiation . Promptly following Pharmacyclics' receipt of Servier's notice that it is exercising its Option with respect to a particular Option Compound, Pharmacyclics and Servier shall commence good faith negotiations regarding the terms under which Pharmacyclics would grant to Servier a royalty-bearing, exclusive, sublicensable right and license under the Pharmacyclics IP to (a) use the Option Compound supplied by Pharmacyclicsfor pre-clinical and/or clinical development activities, and (b) develop, have developed, Manufacture, have Manufactured, use, have used, offer for sale, lease, market, sell, have sold, import and export finished products containing such Option Compound in the Field in the Territory (each such license, an " Option Compound License Agreement "). The Parties shall use good faith efforts to successfully conclude

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such negotiations as soon as reasonably practicable and in any event on or before the end of the period which is [***] after the date of Servier's exercise of the Option (" Negotiation Period ").

3.2.3 Option Compound Return .

If Servier does not give notice with respect to an Option Compound in accordance with Section 3.2.1, or, having exercised its Option in accordance with Section 3.2.1, fails to execute an Option Compound License Agreement prior to the expiration of the Negotiation Period, then any and all rights with respect to such Option Compound shall revert to Pharmacyclics and, thereafter, Servier shall have no right to or interest in such Option Compound.

3.3 Personnel and Resources .

Pharmacyclics agrees to commit the personnel, facilities, expertise, and other resources needed to perform the Research Plan; provided, however, that Pharmacyclics does not warrant that the Research Program shall achieve any of the research objectives contemplated by them.

3.4 Term of the Research Program

Pharmacyclics shall conduct the Research Work under the Research Program during the Research Term. At the end of the Research Term, Pharmacyclics' obligation to conduct the Research Work, will cease unless the Parties mutually agree to extend the Research Term prior to the [***] anniversary of the Effective Date, subject to additional payments, to be agreed upon by the Parties, for research activities conducted by Pharmacyclics during any such extended period. An inventory of all Option Compounds then existing shall be prepared by the Pharmacyclics.

3.5 Expenses

Except as otherwise set forth elsewhere in this Agreement, Pharmacyclics shall bear the costs and expenses of Research Work done pursuant to the Research Program at its laboratories and its affiliated laboratories. For clarity, the cost of synthesis of Option Compound(s) for which Servier has obtained a license pursuant to Section 3.2, and related costs of scale-up and

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process development for such Option Compound(s) shall be allocated between the Parties as set forth in the Option Compound License Agreement.

3.6 Exclusivity

Nothing in this Agreement shall restrict Pharmacyclics from researching, developing, registering and/or commercializing any [***] Inhibitor for any indication(s) in any country or countries in the world, or prevent Pharmacyclics from licensing a Third Party to do the same, however Pharmacyclics agrees that during the Term it will not (a) research, develop, register or commercialize any [***] Inhibitor for use in the Field in the Territory except in connection with its performance of the Research Program, or (b) grant to any Third Party a license to commercialize any [***] Inhibitor for use in the Field in the Territory without having priorly performed its obligations as per article 3.2 above.

ARTICLE 4
DEVELOPMENT, REGISTRATION AND COMMERCIALIZATION

4.1 Clinical and Non-clinical Development

4.1.1 Servier Obligations . Subject to the terms and conditions of this Agreement, Servier shall be responsible at its cost and shall use Reasonable Efforts to develop, register and commercialize the Licensed Products in the Territory in a prompt and expeditious manner, to (a) conduct all development of Licensed Products in the Field in the Territory, including, but not limited to, all design, planning, and performance of human clinical and non-clinical trials and analysis of clinical trials data as may be necessary to register and commercialize the Licensed Products in the Territory, in accordance with the Development Plan; (b) commence human clinical trials as soon as practicable following the Effective Date, and (c) assemble and file Approval Applications and timely communicate with the relevant Governmental Authorities to obtain Regulatory Approval from such relevant Governmental Authorities to manufacture, market, and sell Licensed Product(s). At the end

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of each Calendar Year, Servier will provide an annual report to Pharmacyclics outlining Servier's efforts in connection with development, clinical and regulatory activities relating to Licensed Products, which annual report shall contain at least the following information to the extent applicable to any Licensed Product: completion of GLP toxicology studies, stage of clinical development, and Approval Applications filed and Regulatory Approvals obtained.

4.1.2 Development Plan . Servier will provide Pharmacyclics with the initial development plan for Servier's development of Licensed Products in the Territory (" Development Plan ") within [***] of Effective Date. Servier agrees to provide to Pharmacyclics for its information updated versions of the Development Plan at least annually, and any material modification or addition to the Development Plan within a reasonable period of time prior to implementation thereof.

4.1.3 Change in Formulation . Before modifying the formulation or Dosage Form of a Licensed Product, or developing a Collaboration Compound in combination with another Active Ingredient, each Party shall inform the other Party of the proposed modifications or development prior to its implementation.

4.2 Exchange of Data . Promptly after the Effective Date Pharmacyclics shall provide all Data from any and all clinical trials and preclinical studies of the Collaboration Compounds and/or Licensed Products that are completed as of the Effective Date, as well as the know-how relating to the Manufacture of the Collaboration Compounds and/or Licensed Products to ensure Servier's (or its subcontractors or sub licenses) ability to manufacture the Bulk Form and the Dosage Form of the Collaboration Compounds and/or Licensed Products as soon as possible. During the term of this Agreement, each Party shall provide to the other Party all Data to the extent Controlled by such Party, in a timely fashion and as promptly as possible for use by such other Party in accordance with this Section 4.2. Servier will only use and disclose Data to Third Parties as may be necessary or useful for development, Manufacture, registration, promotion, distribution and commercialization of Products in Territory; or as may otherwise be agreed by Pharmacyclics and Servier. Servier may not

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use any Data (or permit any Third Party to use Data) outside the Territory, nor for any products other than the Licensed Products and Combination Products. Pharmacyclics shall only use or disclose Data provided by Servier to Third Parties as is reasonably necessary or useful for registration and commercialization of Licensed Products outside the Territory, including without limitation for use by any Pharmacyclics' sub- licensee provided that (i) the disclosure of such Data is made under reasonable and customary confidentiality restrictions and (ii) Pharmacyclics undertakes to indemnify and hold harmless Servier, its Affiliates, their respective directors, representatives, agents, officers, employees, successors and assigns from and against any and all "Claims" arising as a result of the use or disclosure of the Data by Pharmacyclics or by a Third Party under a sub-license from Pharmacyclics. For the purpose of this section 4.2, "Claims" means any and all losses, liabilities, costs and expenses, debts and other obligations arising out of or resulting from Third party claims, judgment, damages of any kind whatsoever, arbitral awards and amounts paid in settlement of claims, judgments, legal proceedings and the like. For the purpose of clarity, the foregoing indemnity shall include but not be limited to product liability and similar third party claims.

4.3 Manufacture and Supply of Licensed Products for clinical trials

Subject to the terms and conditions of this Agreement, Pharmacyclics or its Third Party manufacturer shall use Reasonable Efforts to (a) manufacture, or have manufactured, adequate quantities of all Licensed Products in Dosage Form necessary for clinical trials to be conducted, until Servier confirms to Pharmacyclics in writing that Servier has the capability to manufacture them for clinical trials, in the Territory in conformance with the specifications set forth in the respective Approval Applications and any amendments, supplements and substitutes thereto, all in accordance with a supply agreement to be negotiated by the Parties within ninety (90) days after the Effective Date containing terms consistent with this Section 4.3 and such other terms as are reasonable and customary for arrangements of this type. Pharmacyclics shall supply Licensed Products in Bulk Form or Dosage Form at a transfer price equal to its Fully Burdened Cost of Manufacturing Bulk Form or its Fully Burdened Cost of Manufacturing Dosage Form, as applicable, plus [***]% (see

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Exhibits 1.32(a) and 1.32(b), respectively). Servier shall be responsible at its cost for the re-labeling of the Licensed Products as approved by the relevant Governmental Authority.

4.4 Regulatory Submissions

Copies of all draft material submissions submitted after the Effective Date to Governmental Authorities (limited to EMEA and FDA) by each Party in seeking marketing authorization for a reply thereto and to the extent reasonably practicable all other material correspondence with Governmental Authorities covering the Collaboration Compounds and/or Licensed Products shall be provided to the other Party promptly upon draft completion but in no event less than thirty (30) days before being submitted or sent, during which time the Party shall have a reasonable opportunity (not to exceed fifteen (15) days) to review such submissions or correspondence and consult with the other Party with respect thereto. Information provided under this provision shall include but not limited to:

· briefing books and slides relating to consultation meetings with governmental authorities

· IND submissions, initial submissions, serials, annual updates

· Clinical reports of pivotal studies

· module 2 overviews

· Module 2 summaries

· CMC module 3 files

· Draft labeling

· Answers to questions

After any such consultation and taking into consideration any comments from the other Party , the Party shall determine the final form of all material submissions and correspondence in its sole

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discretion. Final copies including clinical database for individual studies, integrated analysis and CRFs of all material submissions and correspondence shall be promptly provided to the other Party.

Governmental approvals: each Party shall provide the other with a copy of the NDA or EMEA approval letter within ten (10) days of its receipt.

4.5 Commercialization

Subject to the terms and conditions of this Agreement, Servier shall be solely responsible at its cost and shall use Reasonable Efforts to (a) implement a strategy for marketing and promotion of the Licensed Products in the Field in the Territory (b) beginning promptly after the receipt of Regulatory Approval for a first Licensed Product in each country in the Territory, commercialize such Licensed Product in such country. At the end of each Calendar Year, after Servier or any Sublicensee of Servier has received Regulatory Approval for distribution, use or sale of a Licensed Product, Servier will provide a written summary to Pharmacyclics outlining Servier's efforts in connection with commercialization activities relating to such Licensed Product.

4.6 Reporting Adverse Drug Reactions/Experiences and exchange of safety information

Promptly following execution of this Agreement the Parties will prepare within ninety(90) days a Pharmacovigilance and quality agreements governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions/experience, Licensed Product quality and Licensed Product complaints, sufficient to permit each Party to comply with its legal obligations. The Pharmacovigilance and quality agreements will be promptly updated if required by changes in legal requirements. Each Party shall keep the other Party informed about any adverse drug reactions such Party becomes aware or is informed about regarding the use of a Licensed Product in or outside Territory. As between the Parties, Servier shall be responsible for reporting all adverse drug reactions/experiences to the appropriate regulatory authorities in countries in the Territory, and Pharmacyclics shall be responsible for reporting all adverse drug reactions/experiences to the appropriate regulatory authorities in countries outside the Territory, in accordance with the appropriate laws and regulations of the relevant countries and authorities.

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Servier shall ensure that its Affiliates and Sublicensees comply with such reporting obligations in the Territory and Pharmacyclics shall ensure that its Affiliates and sublicensees (other than Servier and its Sublicensees) comply with such reporting obligations outside the Territory. These reporting obligations shall apply to other adverse events as described in the Pharmacovigilance and quality agreements including but not limited to adverse events occurring from product overdose or from product withdrawal, as well as any toxicity, sensitivity, failure of expected pharmacological action, or laboratory abnormality which is, or is thought by the reporter, to be serious or associated with relevant clinical signs or symptoms. Each Party will designate a pharmacovigilance liaison to be responsible for communicating with the other Party regarding the reporting of adverse drug reactions/experiences.

4.7 Reports; Inspection

Each Party shall maintain, and shall use Reasonable Efforts to cause its Third Party manufacturers and Third Party contractors to maintain, accurate and complete records of all development work with respect to the Licensed Products, as consistent with the responsibilities of such Party under this Agreement. A Party, or such Party's authorized representatives, may visit those portions of the facilities of the other Party or their Third Party contractors or Third Party manufacturers where development is being performed during normal business hours upon reasonable notice without undue interruption to normal business operations.

4.8 Regulatory Inspections .

If either Party or its Affiliates or subcontractors (each, an " Inspected Party ") are to be inspected by a Government Authority regarding the development, manufacture, registration or commercialization of a Licensed Product, the Inspected Party shall promptly notify the other Party of the inspection in writing as soon as reasonably practicable, and in advance, if any such inspection is a scheduled inspection. The Inspected Party shall, where practicable, permit representatives of the other Party to participate as observers with respect to such inspection, and shall provide the other Party with a written report of any such inspection, noting with specificity any records or documents reviewed by the regulatory inspector, and including copies of any FDA 483s (or their foreign

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equivalent) or written communications provided by or to any Government Authority relating to such inspection. The Inspected Party shall also provide an opportunity for the other Party to assist in responding to any issues or concerns relating to such inspections, and shall provide copies of all communications to and from any Government Authority relating thereto to the other Party. The Parties shall cooperate in good faith and otherwise mutually support any regulatory inspections of facilities, clinical sites, contract manufacturers or the like with respect to the Licensed Product, including by using Reasonable Efforts to make available such facilities, documents, information and/or personnel as are reasonably necessary or useful for such regulatory inspections by a Government Authority.

4.9 Audit Rights

Each Party shall have the right, during normal business hours, and no more than once per year, with more frequent audits upon agreement of the Parties (such agreement not to be withheld unreasonably), to inspect and audit: (a) those portions of the facilities of each Party, or any of its Affiliates, and subcontractors used in connection with the Licensed Products to ascertain compliance with Applicable Laws and Regulatory Approvals, including current GLP, Good Clinical Practices and Good Manufacturing Practices, provided that the inspecting Party shall on such occasions be accompanied by a representative of the other Party; and (b) any of the other Party's documentation, or its Affiliates' or subcontractors' documentation, relating to the Licensed Products and, to the extent permitted by law and any applicable privacy policies, the medical records of any patient participating in any clinical study of a Licensed Product being conducted by such Party or its Affiliates. A Party's audit rights shall be limited by bona fide Third Party agreements or confidentiality obligations, provided, however, that each Party shall use its reasonable efforts to obtain audit and inspection rights for the other Party under such agreements; and if a Party is unable to obtain such audit rights for the other Party, then upon request it shall exercise its own rights with respect to such an audit for the benefit of the other Party.

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4.10 Failure to Develop or Register or Commercialize

The Parties agree and understand that Servier has an obligation to use Reasonable Efforts to develop, register and commercialize Licensed Products. If Servier does not (a) initiate human clinical trials for at least one Collaboration Compound or Licensed Product within [***] after the delivery of clinical supplies or (b) use Reasonable Efforts to commercialize Licensed Products in accordance with Section 4.4, then this Agreement may immediately be terminated under Section 11.3.

ARTICLE 5
FINANCIAL TERMS

5.1 License Fee

In partial consideration of the license rights granted by Pharmacyclics to Servier under this Agreement, Servier shall pay to Pharmacyclics, on the Effective Date and within fifteen (15) days after receipt of the corresponding invoice, an upfront non-refundable and non creditable license fee of Eleven Million Dollars ($11,000,000).

5.2 Research Funding

Servier shall pay to Pharmacyclics a non-refundable and non-creditable total of Four Million Dollars ($4,000,000) to fund Pharmacyclics' conduct of the Research Program during the first two (2) Contract Years of the Term, such total amount to be paid as follows:

Contract Year	Payment
1	$2,000,000
2	$2,000,000

Payments from Servier to Pharmacyclics pursuant to this Section 5.2 shall be paid in four (4) equal installments. The first such installment shall be due on the latter of the Effective Date or October 1 ^st , 2009, the second installment shall be paid six months after the first installment. The third installment shall be paid six (6) month after the second installment and the fourth installment shall be paid

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six months after the third one. Each payment shall be made with fifteen (15) days after receipt of the corresponding invoices.

5.3 Milestone Payments .

Servier shall make milestone payments to Pharmacyclics based on achievement of clinical development milestones as set forth in this Section 5.3 below. Servier shall promptly notify Pharmacyclics in writing of the first achievement of each of the milestones in the table below and the corresponding milestone payment shall be due within thirty (30) Calendar Days of occurrence thereof and fifteen (15) days after receipt of the corresponding invoices. Each milestone payment from Servier to Pharmacyclics shall be non- refundable and non-creditable. For purposes of clarification, none of the payments by Servier specified in this Section 5.3 may be applied to or otherwise credited against any other payment that may be due to Pharmacyclics under the terms of this Agreement. Each milestone payment shall only be paid once irrespective of the number of Licensed Product(s) and/or Combination Product(s) developed and/or commercialized.

Milestones	Payment
[***]	$[***]
[***]	$[***]
[***]	$[***]
[***]	$[***]
[***]	$[***]
Total of all possible milestone payments	$24,500,000

5.4 Royalties

Servier shall pay a running royalty of [***]% on the Net Sales of Licensed Product sold by Servier, its Affiliates and Sublicenses in the Territory. Such royalties shall be payable on Net Sales from the date of First Commercial Sale on a Licensed Product-by-Licensed

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Product and country-by-country basis until the later of (a) expiration of all Valid Claims covering the Licensed Product in such country or (b) any other exclusivity protection of the Licensed Products in such country (e.g., regulatory data protection for new chemical entities, data exclusivity periods (such as periods under national implementations of Article 9.1(a)(iii) of Directive 2001/EC/83, and all international equivalents), Orphan Drug Status etc.), provided that in the event of the launch of a generic version of a Licensed Product in a given country for which royalties would otherwise be due under this Article 5, and thereafter, until the latter of the expiration of all Valid Claims covering such Licensed Product in such country, Servier shall pay to Pharmacyclics a royalty equal to [***] of the applicable royalty rate indicated above (i.e., [***]%) on Net Sales of such Licensed Product or any other exclusivity protection of the Licensed Product in such country. Notwithstanding anything to the contrary, in the event that Servier, or any of its Affiliates or Sublicensees, receives consideration for the sale or other disposition of a Licensed Product prior to the date of First Commercial Sale of such Licensed Product, including

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