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JOINT DEVELOPMENT AGREEMENT

Development Agreement

JOINT DEVELOPMENT AGREEMENT | Document Parties: Medicis Pharmaceutical Corporation | Perrigo Israel Pharmaceuticals, Ltd You are currently viewing:
This Development Agreement involves

Medicis Pharmaceutical Corporation | Perrigo Israel Pharmaceuticals, Ltd

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Title: JOINT DEVELOPMENT AGREEMENT
Governing Law: Arizona     Date: 5/11/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

JOINT DEVELOPMENT AGREEMENT, Parties: medicis pharmaceutical corporation , perrigo israel pharmaceuticals  ltd
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Exhibit 10.4

      ***  INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

JOINT DEVELOPMENT AGREEMENT

     THIS JOINT DEVELOPMENT AGREEMENT (this “ Agreement ”) dated as of April 8, 2009 (the “ Effective Date ”) is entered into between Medicis Pharmaceutical Corporation, a Delaware corporation with offices located at 7720 North Dobson Road, Scottsdale, Arizona 85256 (“ Medicis ”), and Perrigo Israel Pharmaceuticals, Ltd., an Israeli Company with offices located at 25 Lehi Street, B’nei Brak ISRAEL (“ Perrigo ”).

     WHEREAS, Perrigo has the expertise and know-how to conduct a joint development program with Medicis to research and develop the Product (as defined below); and

     WHEREAS, Medicis desires to collaborate with Perrigo regarding the research and development of the Product, all on the terms and conditions of this Agreement.

     NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

     1.  DEFINITIONS.

          1.1 “ Affiliate ” means, with respect to any entity, any other entity that directly or indirectly controls, is controlled by, or is under common control with, such entity. An entity shall be regarded as in control of another entity if it owns, or directly or indirectly controls, at least fifty percent (50%) of the voting stock or other ownership interest of the other entity, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other entity by any means whatsoever.

          1.2 “ Business Day ” means any day other than a Saturday, Sunday or a day on which banks in Arizona are authorized or required by law to close.

          1.3 “ Confidential Information ” means all non-public materials, information and data concerning the disclosing party and its operations that is disclosed by the disclosing party to the receiving party pursuant to this Agreement, orally or in written, electronic or tangible form, or otherwise obtained by the receiving party through observation or examination of the disclosing party’s operations. Confidential Information includes, but is not limited to, information about the disclosing party’s financial condition and projections; business, marketing or strategic plans; sales information, customer lists; price lists; databases; trade secrets; product prototypes and designs; techniques, formulae, algorithms and other non-public process information. Notwithstanding the foregoing, Confidential Information of a party shall not include that portion of such materials, information and data that, and only to the extent, the recipient can establish by written documentation: (a) is known to the recipient as evidenced by its written records before receipt thereof from the disclosing party, (b) is disclosed to the recipient free of confidentiality obligations by a Third Party who has the right to make such disclosure without obligations of confidentiality, (c) is or becomes part of the public domain

 


 

through no fault of the recipient, or (d) the recipient can reasonably establish is independently developed by persons on behalf of recipient without the use of the information disclosed by the disclosing party.

          1.4 “ Development Plan ” means the plan for the research and development of the Product as set forth on Exhibit A, and as such plan may be amended, supplemented or restated from time to time by mutual written agreement of the parties.

          1.5 “ Development Program ” means the development program described in the Development Plan.

          1.6 “ Exclusion Lists ” mean: (a) the HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://www.oig.hhs.gov) ; and (b) the General Services Administration’s List of Parties Excluded from Federal Programs (available through the Internet at http://www.epls.gov ).

          1.7 “ FDA ” means the United States Food and Drug Administration or any successor entity thereto.

          1.8 “ FD&C Act ” means the United States Federal Food, Drug and Cosmetic Act, as may be amended from time to time.

          1.9 “ Ineligible Person ” means a person who: (a) is currently excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or non-procurement programs; or (b) has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible.

          1.10 “ NDA ” means a New Drug Application as defined in the FD&C Act or FDA Regulations (21 CFR).

          1.11 “ Net Sales ” means the gross price invoiced by Medicis or its Affiliate to a retailer or distributor for the Product, as applicable, less the sum of the following items (to the extent actually incurred or accrued and to the extent not already deducted in computing the total amount invoiced by Medicis): (a) credits or allowances actually granted, if any, for recalls, rejection or return of items previously sold, (b) rebates and cash discounts actually granted, (c) *** (d) excise taxes, sales taxes, duties or other taxes imposed upon and paid with respect to such sales ***, (all such amounts determined in accordance with GAAP applied in a manner consistent with past practices). Sales between Medicis and its Affiliates shall not be included in Net Sales unless such Affiliate is the end user of the Product.

          1.12 “ Perrigo Know-How Rights ” means all trade secret and other know-how rights in and to all data, information, compositions and other technology (including, but not limited to, formulae, procedures, protocols, techniques and results of experimentation and testing) which are necessary or useful to make, use, develop, sell or seek regulatory approval to market the Product and which Perrigo has an ownership or (sub)licensable interest as of on or after the Effective Date.

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          1.13 “ Perrigo IP Rights ” means the Perrigo Patent Rights and Perrigo Know-How Rights.

          1.14 “ Perrigo Patent Rights ” means (a) the patents and patent applications listed on Exhibit B, (b) all patents and patent applications in any country of the world that claim or cover the Product or the manufacture or use thereof in which Perrigo has an ownership or (sub)licensable interest as of on or after the Effective Date, (c) all divisions, continuations, continuations-in-part, that claim priority to, or common priority with, the patent applications described in clauses (a) and (b) above or the patent applications that resulted in the patents described in clauses (a) and (b) above, and (d) all patents that have issued or in the future issue from any of the foregoing patent applications, including utility, model and design patents and certificates of invention, together with any reissues, renewals, extensions or additions thereto.

          1.15 “ Product ” means *** product, as described in the Development Plan to be prepared by the parties.

          1.16 “ Product Technology ” means all discoveries, inventions, improvements and other technology that specifically relates to the Product and is conceived or reduced to practice by Perrigo, Medicis or both in the conduct of the Development Program.

          1.17 “ Royalty Term ” means the period commencing on the date of first commercial sale of the first Product and expiring *** thereafter.

          1.18 “ Steering Committee ” means the committee composed of representatives of Perrigo and Medicis described in Section 2.3 below.

          1.19 “ Third Party ” means any person or entity other than Medicis, Perrigo or their respective Affiliates.

          1.20 “ Valid Claim ” means ***

     2.  DEVELOPMENT PROGRAM; STEERING COMMITTEE.

          2.1 Overview . Perrigo timely conduct the Development Program in accordance with the Development Plan. Perrigo shall bear its own costs to conduct the Development Program.

          2.2 Amendment of Development Plan . The Development Plan may be amended from time to time, only upon recommendation of the Steering Committee and upon mutual written agreement of Medicis and Perrigo.

          2.3 Steering Committee . The Steering Committee shall foster the collaborative relationship between the parties and shall in particular have the oversight and responsibility to review and give recommendations regarding the progress of the Development Program. The Steering Committee shall be comprised of three (3) named representatives of Perrigo and three (3) named representatives of Medicis. Each party shall appoint its respective representatives to the Steering Committee from time to time, and may substitute one or more of its representatives, in its sole discretion, effective upon notice to the other party of such change

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but shall use commercially reasonable efforts to maintain stability of Steering Committee representation. As provided in Section 2.6, for each calendar quarter during the term of the Development Program, Perrigo shall provide to the Steering Committee a report that details the progress and results of the Development Program. The Steering Committee shall review such report and make recommendations regarding changes to the Development Program. No such changes shall be binding unless the Development Plan has been amended by the parties as required herein. The term of the Steering Committee shall commence on the Effective Date and continue until the date when Perrigo has completed all of its obligations under the Development Plan.

          2.4 Conflict . In the event that the terms of the Development Plan are inconsistent with the terms of this Agreement, this Agreement shall control, unless otherwise explicitly agreed to in writing by the parties. The Development Plan shall be incorporated herein by reference and made a part of this Agreement.

          2.5 Records . Perrigo shall maintain complete and accurate records of all work it conducts under the Development Program and all results, data and developments made in connection therewith. Such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of the Development Program in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Medicis shall have the right to review and copy such records (including raw data and scientific notebooks) at reasonable times to the extent necessary for Medicis to exercise its rights under this Agreement.

          2.6 Reports . Within thirty (30) days following the end of each calendar quarter during the term of the Development Program, Perrigo shall prepare and deliver to Medicis a written summary report which shall describe the research performed to date under the Development Program and all results, analysis and conclusions thereof.

     3.  INTELLECTUAL PROPERTY/MARKETING.

          3.1 Research License . During the term of the Development Program, Medicis hereby grants to Perrigo a non-exclusive license (without the right to grant sublicenses) under Medicis’ patents, know-how and other intellectual property rights for the sole purpose of conducting the Development Program.

          3.2 License Grant . Perrigo hereby grants to Medicis a worldwide, perpetual, irrevocable exclusive license (with the right to grant sublicenses through multiple tiers) under the Perrigo IP Rights to make, have made, use, offer for sale, sell and import the Product. For avoidance of doubt, the exclusive license is strictly limited to the Product and does not cover rights to the Perrigo IP Rights for any product other than the Product. The foregoing license shall survive the termination or expiration of the term of the Agreement for any reason.

          3.3 Product Technology . Perrigo shall promptly disclose to Medicis all Product Technology. Medicis shall solely own all right, title and interest in and to the Product Technology and all patent and other intellectual property rights therein. Perrigo hereby assigns to Medicis all of its right, title and interest in and to the Product Technology and all patent and

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other intellectual property rights therein. Perrigo shall perform, during and after the term of this Agreement, all acts that Medicis reasonably deems necessary or desirable to permit and assist Medicis, at Medicis’ expense, in obtaining, perfecting and enforcing the full benefits, enjoyment, rights and title throughout the world in the Product Technology and all patent and other intellectual property rights therein. If Medicis is unable for any reason to secure Perrigo’s signature to any document required to file, prosecute, register or memorialize the assignment of any rights to the Product Technology as provided under this Agreement, Perrigo hereby irrevocably designates and appoints Medicis and Medicis’ duly authorized officers and agents as Perrigo’s agents and attorneys-in-fact to act for and on Perrigo’s behalf and instead of Perrigo to take all lawfully permitted acts to further the filing, prosecution, registration, memorialization of assignment, issuance and enforcement of such rights, all with the same legal force and effect as if executed by Perrigo. The foregoing is deemed a power coupled with an interest and is irrevocable. Medicis shall have the world-wide right to control the drafting, filing, prosecution, maintenance and enforcement of patents covering the Product Technology and shall be fully responsible for related costs.

          3.4 No Implied Licenses . Except as explicitly set forth in this Agreement, neither party grants to the other party any license, express or implied, under its patents or other intellectual property.

          3.5 Marketing of Product . Medicis shall have the sole right to make, use, sell, distribute, market, exploit or otherwise commercialize the Product. Perrigo acknowledges and agrees that, except as otherwise provided under this Agreement it shall have no right to and it shall not (and shall not assist any third party to), make, have made, use, sell, distribute, market, exploit or otherwise commercialize the Product.

          3.6 Regulatory Matters . Medicis shall have the exclusive responsibility, at its sole discretion, for all preclinical, clinical, regulatory and commercialization activities regarding the Product, including without limitation marketing, pricing, promotion, strategy, reimbursement, branding, distribution, and sale. Medicis shall bear its own costs in connection with any such activities, including the costs for conducting all pre-clinical and clinical studies. ***

     4.  SUPPLY OF PRODUCT.

           4.1 Terms of Supply Agreement . Commencing on the date the Product NDA has been submitted to the FDA (the “ Supply Date ”), the parties shall negotiate in good faith the terms of and enter into a commercial supply agreement, which shall contain the following provisions:

                 4.1.1 For a period of three (3) years following approval of the NDA for the Product, Medicis would exclusively purchase from Perrigo, and Perrigo would exclusively supply to Medicis all of Medicis’ Product requirements in the United States, subject to Medicis’ right to qualify alternative manufacturers for the Product.

                 4.1.2 Perrigo would be responsible for manufacture, delivery and supply of the Products.

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               4.1.3 Medicis would have the option to procure an alternative manufacturer and supplier for the Products in the event Perrigo has a material supply interruption or otherwise failed to supply Medicis’ requirements of Product.

               4.1.4 Perrigo would cooperate and assist in the transfer of all necessary technical information to qualify the alternative manufacturer and in the event of a material supply interruption, would cooperate and assist with the orderly transition of the manufacture of Products to the alternative manufacturer.

               4.1.5 The price for the Product would be *** of Perrigo’s direct cost to manufacture the Product, calculated in accordance with GAAP.

          4.2 Arbitration . If the parties are unable to agree upon the terms of the supply agreement described in Section 4.1 within sixty (60) days after the Supply Date, then either party may, by written notification to the other party, submit the matter to binding “baseball” arbitration to determine the terms of such supply agreement as follows. Promptly following receipt of such notice, the parties shall meet and discuss in good faith and agree on an arbitrator to resolve the issue, which arbitrator shall be neutral and independent of both parti


 
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